CLINICAL TRIAL COORDINATOR Clinical Trials Unit Beatson West of Scotland Cancer Centre

Transcription

1 CLINICAL TRIAL COORDINATOR Clinical Trials Unit Beatson West of Scotland Cancer Centre Job Reference: G Closing Date: 7 th April 2017

2 Dear applicant, Thank you for your interest in this post and for taking the time to read this information pack. We hope this exciting and rewarding role catches your imagination and that you are encouraged to apply. As the largest Health Board in Scotland, NHS Greater Glasgow and Clyde plays a vital role in the education and training of doctors, nurses and other health professionals, working closely with local universities and colleges. It also provides the full range of community hospital services. The Board has an annual turnover of 3.2 billion per year. It serves a population of 1.2 million people and employs 39,000 staff. Along with many NHS providers, the Board must respond vigorously to operational, quality and financial challenges in order to continue to improve outcomes for, and the experience of, our patients and the communities we serve. The Board is a large organisation operating in an increasingly tough environment. Building enduring relationships with our partners is vital to continue to drive the changes we are making. Effective communication and productive dialogue is challenged by the spread of the organisation s sites and stakeholders over a wide geographical area, as well as the variety and large number of partners we work with. The Board is managing these challenges and has developed a positive platform to continue to improve towards excellence. To drive forward these improvements the Board must have the ability to make tough decisions at a time of change. The next step in the Board s journey is essential: to build and deliver a strategy that will engage the workforce and public in changing for the future to provide sustainable healthcare services, further embed a culture of innovation and meet the demands and exceed the expectations of our patients. The following is included in this information pack to help you with your application: Job description Person specification A summary of the terms and conditions for the post The application process Guidance for completing your application form Working for NHS Greater Glasgow and Clyde If you have a disability or long-term health problem, the Board is committed to offering reasonable adjustments throughout the recruitment process and employment. If you require further information or support, please contact Recruitment Services. We very much look forward to receiving your application. Recruitment Services

3 Cancer Research UK West Of Scotland Clinical Trials Unit Beatson West of Scotland Cancer Centre Glasgow Job Description 1. JOB IDENTIFICATION Job Title: Department(s): Job Reference number (coded): Clinical Trial Co-ordinator (CTC) Cancer Research UK Clinical Trials Unit (CTU) Beatson West of Scotland Cancer Centre, Glasgow (BWoSCC) 2. JOB PURPOSE To coordinate and manage a broad portfolio of phase I-III Clinical Trials in oncology, working in accordance with ICH GCP (Good Clinical Practice) and the EU Directive, providing efficient data management for all studies run through the CRUK Clinical Trials Unit, Glasgow. 3. ORGANISATIONAL POSITION Please refer to the current version of the Cancer Research UK Clinical Trials/Research Unit Glasgow Organisation Chart.

4 4. SCOPE AND RANGE The Cancer Research UK Clinical Trials Unit Glasgow is based within the Beatson West of Scotland Cancer Centre, Glasgow and is one of the 3 major Cancer Research UK Trials Offices within the UK. The Beatson West of Scotland Cancer Centre is the lead centre for the delivery of non-surgical cancer care for the West of Scotland. It serves a population of 2.8m, and has clinical links with 16 hospitals in five surrounding health board areas. The Beatson is Scotland s largest cancer centre, and the second-largest in the UK. As a result, the workload is varied each year, the Beatson team sees over 8,000 new patients, and more than 14,800 courses of chemotherapy and 6,350 courses of radiotherapy are administered. Waiting times for radical treatment are usually among the lowest in the UK. The main purpose of the CTU is to advance cancer treatment and knowledge by recruiting patients into clinical trials and documenting their treatment for independent review. CTCs provide organisation and support for 19 clinical and 5 medical oncologists wishing to give their patients with cancer access to a clinical trial. The CRUK CTU Glasgow is one of the major cancer clinical trial units in the UK and is a joint partner in the Cancer Clinical Trials Unit Scotland (CACTUS), one of only 9 National Cancer Research Institute accredited units in the UK. The unit deals with large, multi-centre trials (EORTC, MRC), translational trials (Cancer Research UK) and industry sponsored early clinical studies. There approximately 90 open studies running through the department in 13 different tumour types with approximately 1317 patients on study treatment. Data continues to be collected and managed for over 1700 patients on trial follow-up. There are a wide variety of trials which run through the department. Large, randomised, Phase III trials which can recruit over 1000 patients are co-ordinated from here. There are studies which are translational (lab work) and require blood sampling and tumour sampling to be performed and shipped. Phase I studies are drugs first in human, and require intensive data collection and monitoring of patients. More on this can be found on the Unit s website

5 5. MAIN DUTIES/RESPONSIBILITIES Each CTC has their own workload. This can include 10 recruiting studies at any one time (in addition to the follow up of closed studies). Many of the studies coordinated from our centres follow patients up until death. The department has their own set of SOPs (Standard Operating Procedures), which each CTC works to, ensuring uniformity within the office. The department also adheres to the ICH GCP Guidelines and more recently the EU Directive on Clinical Trials. The EU Directive came into force on 1 st May 2004 and is a legal requirement for participation in Clinical Trials. 1. Providing co-ordination and data management to allocated clinical trials that are run through the CRUK CTU. This involves: Checking patients are eligible for a clinical trial by reviewing the inclusion and exclusion criteria of the study in conjunction with the patient s clinician; Randomising/registering patients for treatment and relaying the treatment allocation to the responsible clinician; Ensuring that investigations (e.g. blood tests, CT-scans, Quality Of Life Questionnaires) are carried out as per the study protocols. This involves close liaison with various members of the hospital staff from a wide range of departments. This includes having clinicians measure patients CT scans for documentation of disease in the patients CRF (Case Report Form); Review/extract data from hospital notes onto case report forms (CRFs) for patients on study and ensuring the data is accurate and up to date. CTCs must discuss the data collection with the clinician to ensure that information is documented to verify source data. This includes documenting patient s previous medical history, physical examinations, laboratory results, medications taken throughout treatment with appropriate start and stop dates, adverse events occurring throughout the study (again with appropriate start and stop dates); Requesting and sending pathology samples or CT scan reports for independent review. Some trials co-ordinated from this centre are what are referred to as Biological Studies. This is where patients are consented to provide blood and/or tumour samples. In this case, the CTC is responsible for the labelling, packaging and couriering of these samples both from their own centre and other centres involved in the studies. The transfer of biological material is strictly regulated, and IATA guidelines have to be adhered to; The majority of patients will initially be seen at other hospitals before they are referred to the BOC for their treatment. This may result in a lot of missing information from the patient BWoSCC notes about their medical history,

6 previous investigations etc. The CTC will contact the other hospital to request any missing information; Reporting all Serious Adverse Events (SAEs) that occur in trial patients to the study sponsor as outlined in the protocol; Answering any queries that may be generated from the data collected within specified timelines. Clarification of the data must be discussed and signed by the clinician responsible for the study; Liaising with the responsible hospital personnel regarding the trial and updating the CRUK CTU staff with any study updates; Organising start-up visits for new studies, ensuring all the study personnel are in attendance (i.e. clinician, pharmacists, nurses, CTC) and all regulatory documentation is in place; Attending start-up visits, throughout Europe and the Rest of The World, with the clinician responsible for the study (or alone as their representative) to go through all the study procedures before any patients have been recruited; Working regularly with drug company representative responsible for monitoring study data. This would involve organising a meeting room and making sure all the patient data is available and up-to-date. Feed back any issues from this meeting to the clinician to address any queries or problems that may arise; Some trial patients on follow up are seen at peripheral clinics. If they remain on study treatment (eg. maintenance treatment), the CTC can on occasions act as a liaison between the BWoSCC pharmacy and peripheral clinic to ensure that the prescription is available for the patient to receive when they attend. This can either involve the CTC taking the prescription to the clinic in person or arranging for another member of staff to pick this up from the CTU; Passing on information to other study personnel when new information becomes available e.g., unexpected side effects which can result in the suspension of the clinical trial and require existing patients to stop study treatment. 2. Involvement in the design of protocol and case report forms for in-house trials to ensure that all the required data has been captured, the forms are accurate and reflect the protocol requirements. 3. Write CRF completion guidelines for in-house trials. This involves detailing exactly the manner in which forms should be filled in before being returned to the department. This can include simple things like date format (dd/mm/yyyy), to more complex instructions on how to document adverse events and how response to treatment is calculated. 4. For In-House Trials, the CTC will be involved in the review the data management plan for the study. This involves:

7 Drafting data entry conventions for data received and entered onto the Oracle database. This involves writing instructions for each study which have to be followed to ensure the accurate input of data onto the database. An example would be if a patient has filled in a Quality of Life form (these generally tend to have a score of 1-5 with the patient having to circle the appropriate number) and have circled more than one number. The database can only accept one answer per question. In this scenario, data entry conventions would dictate that the worst score is entered; Reviewing computer generated edit checks to ensure they are accurate, clear and concise for clarification of the data; Visual check on the data and crosschecking the data between differing CRF forms. Treatment response data are compared to previous disease documentation to ensure the documented response given has been calculated correctly according to the response criteria, e.g, SWOG and RECIST Guidelines have to be adhered to; Liaison with the statistician and computer manager to review the coding and CRF pages to ensure that all the required data is collected and entered in the most efficient and manageable way. 5. For some In-House Trials, the CTC may have to process data sent to the CTU from other hospital sites. This would involve: Entering data onto the Clinical Trials Database; Generating queries by manual review and electronic edit checks, which are then distributed to the site in question; Resolving any queries returned from centres involved in the study; Keeping the database up to date by contacting sites requesting overdue CRF pages; Answering queries other centres may have or being intermediary between the site and the Chief Investigator to discuss medical / eligibility matters; Maintaining good communication links with all other centres involved with a specific study and informing the study personnel regarding any relevant trial developments. If the study is international this can involve discussion (teleconferences) with study representatives from foreign countries, clarity in these cases is essential; When co-ordinating a study from this site, the CTC will help the Regulatory Administrator in the CTU process the Ethics Application. This involves sending all the essential documents to the Ethics Committee and ensuring proper approval has been given before the study can open to recruitment. It is then

8 the responsibility of the CTC to pass these documents onto the other hospital sites so that they can apply to participate in the study; Requesting and reviewing relevant documentation to ensure that any site participating in the study has the knowledge and experience to treat patients within the study protocol. This involves obtaining the CVs of the other site personnel, ensuring they have R&D approval, laboratory accreditation certificates and normal ranges. Once another site has been open to recruitment the Co-ordinator must supply the site with all relevant study supplies, e.g., CRFs, registration forms, SAE forms etc; In the absence of the QA Manager, the CTC may be requested to oversee the logging and reporting of the SAEs/SUSARs (Suspected Unexpected Serious Adverse Reactions) that have occurred on the study. CTCs will attend Data Monitoring Committee Meetings for studies they are coordinating. This is where interim analyses are performed and the results looked at by an independent panel to ensure the study is recruiting properly and that there are no safety issues. The CTC will compile these reports in conjunction with the statistician; The Clinical Trials Unit works closely with the NCRN (National Cancer Research Network, England) and the SCRN (Scottish Cancer Research Network). These are government funded bodies to increase recruitment into clinical trials. CTCs are responsible for applications for their studies (non-commercial only) to the NCRN for adoption. 6. CTCs will be expected to attend meetings, give study updates (including public speaking) and compile reports on their studies when necessary. 7. CTCs regularly attend Phase I meetings within the Unit department to review their patients progress and report any data collection/study issues to the clinicians and research nurses. 8. CTCs will be relied upon to give help, advice and training to new staff on completing CRF s, dealing with clinicians and departmental policy. 9. Archiving of the study material as per departmental standard operating procedures (SOP s). 10. On occasions, one or more of the CTCs in the CTU may be asked to undertake projects out with their job description. These requests are reviewed on an individual basis and mainly involve projects to review/assess the feasibility of introducing new data management processes in the Unit;

9 11. General office duties will include answering the telephone, photocopying, filing, faxing and any other duties necessary to help with the smooth running of the trials unit. 6. SYSTEMS AND EQUIPMENT The position involves the use of the following equipment and software: Oracle Database - The database is used to store information on all patients entered into clinical trials. For our records, and safety purposes we can enter certain details of every patient entered into a clinical trial (amount of detail depends on the hospital the patient is being treated at). In certain trials, patients would be randomised by the database. This determines which treatment arm of the study the patient is assigned to. All data for studies co-ordinated from the department is entered onto the database The database can generate queries on the entered data if data does not make sense, if certain investigation results seem excessive or inaccurate. Oracle can run multiple reports, ranging from outstanding data number of patients entered on a specific trial, workloads for CTCs. CIS & Other Hospital Systems - Hospital patient information system. This is used for information on patient s appointments, admissions to hospital and as tracering system to locate case notes. Biochemistry, Haematology, Pathology, Radiology and Bacteriology information systems are all used to obtain access to patient s results. Microsoft Word - Compile reports, type letters and general administration. A high proficiency in Word is required to ensure that the study will run smoothly. Adobe Acrobat Reader - Allows conversion of documents created in other programs into Adobe to enable sending or comment and review as a PDF file Powerpoint - To create presentations and handout reports for review. Excel - Create spreadsheets, useful for tracking patients treatment, adverse events and scheduling follow-up appointments or timelines for scans. (Outlook Express) To communicate with all people involved with clinical trials, circulate reports and information on studies. Especially important when working with overseas centres as differing time zones can make contacting sites difficult. Case report forms (CRF s) Used to collect the data required for the study in a clear and

10 precise format. This involves liaising with the patient clinician to ensure that all the information is accurate and all the protocol investigations have been performed. Increasingly these are provided by the company as computerised ecrf s. ecrf s are completed either as remote data entry on a laptop or are a web based system. Specialised training in the function of the new system is required before the study can open to recruitment. IVRS/Clinphone systems Telephone system used mainly in blinded studies designed to register/randomised patients, supply medication, allocate patient Kit numbers (these are held in pharmacy, each patient being allocated a different number for each treatment), break blinding codes (this is done in an emergency), etc. Chemo Care4 This is the hospital system used for prescribing patients chemotherapy. This is used frequently to check whether the patient has received treatment or not and the details of this. Department Systems It is each CTC s responsibility to monitor their patient s treatment whilst on study. This involves keeping a study log documenting all patients enrolled in a particular trial. This will show how many patients are currently on study and what stage of treatment they are at. Prompts are used in case notes to remind clinicians of what investigations the patient will require at each study visit as per protocol. 7. DECISIONS AND JUDGEMENTS CTCs are given a number of studies to work on and it is their responsibility to prioritise and manage their workload in order to work efficiently. CTCs can be responsible for up to 10 recruiting studies at any one time in addition to closed studies on follow up. Studies on follow up can involve a lot of data being collected and entered onto the database. Some studies co-ordinated from this centre can recruit patients. This can entail having to co-ordinate many centres throughout the UK (can sometimes be up to 70) and, in some instances, throughout Europe, USA and Australia/New Zealand. The magnitude of these studies add to the CTCs workload, along with other smaller studies they may be running. Deadlines for study data return will be imposed and CTCs must meet these deadlines whilst dealing with the day-to-day management of other studies such as queries, reporting serious adverse events and answering urgent telephone calls. Decisions regarding time management must be applied to each working day to ensure that work is up-to-date and accurate. There is no direct supervision on day-to-day working practices although the Head of Trial Co-ordination would be made aware of any significant problems with any studies after all attempts to resolve the problem have been made by the CTC responsible for the study. Each CTC should have highly specialised working knowledge of all their studies to be able to answer questions from clinicians, nurses and other personnel involved with

11 patients on study treatment. It is essential that any questions regarding a study are answered quickly and accurately so that the patient s treatment is in no way compromised. This can include patients who require dose modifications whilst on treatment. This means you must interpret how serious/urgent the information is and judge when to discuss with the clinician/company or use your knowledge of the study to answer this yourself. The protocol for each study includes the trial outline and objectives, inclusion/exclusion criteria, study medication and treatment plan, clinical assessments, laboratory assessments, statistics and analytical plan, data monitoring committee, interim analyses and the trial management group, adverse events, withdrawal, follow up and subject replacement policy, definition of progressive disease etc. CTCs will receive requests from companies for additional information regarding the study patients - sometimes the request is not always appropriate for example if the patient were on a previous study we would not disclose the treatment given due to confidentiality. This is just one example of many requests that occur where CTCs must judge what information is appropriate to disclose and ensure that this is within the guidelines of the data confidentiality act. Sometimes drug companies will apply pressure for more information or data about a patient on treatment. In these cases the CTC must use their judgement to decide if we need take action or have further discussion regarding the appropriateness of the request. For example, a patient that experiences an adverse drug reaction can be admitted to hospital with other complaints. Companies will often request you complete a form for each complaint but CTCs must decide which events merit reporting (after discussion with the responsible clinician). This can cause conflict with the company personnel. In these cases CTCs must argue the case using tact and diplomacy. The CRUK CTU co-ordinates some studies whereby the Chief Investigator (CI) is off-site (at another hospital, e.g, London or Leicester). This can cause problems when there are eligibility/treatment queries regarding patients on the study. The CTC has to have a communication system set up so that they can get in touch with the CI at all times. However, this is not always possible or if this is not possible, identify this in advance and have an alternative contact (eg another investigator). 8. COMMUNICATIONS AND RELATIONSHIPS The appointee will be expected to communicate and develop good working relations with the following bodies/people: Clinicians - CTCs have various levels of communication with the clinicians who are involved

12 with and participating in the studies they co-ordinate and manage. This will involve the Chief Investigator (in charge of the study as a whole), the Principal Investigator (lead clinician at each site) and any SpRs working on the study. This may range from registering a patient into a trial to arranging a time to meet to have CRF pages signed off and ensure data is upto-date and accurately transcribed from the case notes. Clinicians can on occasions also request study updates for patients on studies. This would require compilation of reports detailing patient s status within the study and in some cases, relaying this information at departmental meetings. Communication with the study clinicians requires the CTC to use their discretion as and when to make demands on the clinician s valuable time. When working on drug company studies the CTC is the main point of contact for the study and works as an intermediary between the clinician and the company representative. This involves answering queries from both parties, organising meetings and informing all study personnel of any study updates. CTCs would be expected to communicate any problems or concerns our clinicians may have with the study to the company representative and to inform our clinicians of the company s procedures and expectations. To discuss with the clinician any side effects of the patients treatment to establish if this is related to the study drugs and report to the drug company if necessary. Prompting the clinician via case notes to ensure that any investigations required by the study are performed. Drug Company Representative - All data collected for any study must be monitored regularly. Visits to the department are scheduled to have all CRF s audited ensuring that the data is accurate. Telephone calls, faxes or s requesting data clarifications and patient updates are also common place. This involves discussion between CTC, drug representative and clinician. Other Hospital Personnel - When working on a study co-ordinated from our centre, the CTC will be the main point of contact for all the centres participating in the study. This includes all clinicians and study personnel. If there is a query regarding a patient s care or treatment then the CTC will be contacted in the first instance. It is then the responsibility of the CTC to discuss this with the Chief Investigator for the study and relay this back to the relevant study personnel. CTC are also responsible for randomising patients and requesting urgent missing data or data clarification on studies that are being analysed. In dealing with other CTCs tact and diplomacy must be used at all times as it is essential to any study that these important communication links are maintained. Statisticians - liaise with regarding the format and content of CRF s, writing data entry conventions and CRF completion guidelines to ensure that the data is collected in a clear and precise manner. During a study analysis close communication with the statistician is required to clarify any data queries and request any missing data to ensure the analysis is valid. The statistician also requests information on in-house studies for the In-house Steering Committee meetings. This involves the CTC commenting on the running of the study, any problems they may be having and also requested comments from the Chief Investigator for the study.

13 Computer Manager/Programmer - to ensure that the Oracle database is programmed efficiently and modified specifically to suit each individual study. Report problems and request help with the computer systems to ensure they are being used to maximise efficient working practice. CTCs also have to test all the pages set up on Oracle for their particular study to ensure that these are functioning in the correct manner before the study opens to recruitment. Research nurses All Phase I and the majority of Phase II studies have research nurses allocated to them. CTCs are their main point of contact for any queries regarding the study treatment or scheduling of investigations. Working closely with research nurses is essential when they are performing assessments as per protocol for the study. Ethics to ensure that all necessary approvals for the study have been granted. In studies co-ordinated from our centre, it is essential to have good communication with the ethics committee who have approved that particular study as there will be direct communication with them regarding the addition of new centres, any protocol amendments etc. Research and Development to ensure that all necessary approvals for the study have been granted. The R&D department for the hospital now provide sponsorship for non-commercial studies run through the department. The CTC has to liase between the R&D department and the other sites when setting up clinical trial agreements and sponsorship requirements. MHRA (Medicine and Healthcare Regulatory Authority) in accordance with the EU Directive, the MHRA is the Competent Authority of the UK. All studies have to have a Clinical Trials Authorisation if they involve an IMP (Investigational Medicinal Product) this is a legal requirement. The MHRA have to be informed of all SAEs/SUSARs, any other safety issues arising, and any protocol amendments. Pharmacy the Pharmacy department have a designated clinical trials pharmacist and clinical trials technicians. CTCs liase with them on a regular basis going through trial protocols and assisting with interpretation in conjunction with either the Chief Investigator for the study or the Pharmaceutical Companies. Pathology close working relationships have to be established with pathology due to the increasing number of studies that require samples from patients surgery. Trials Unit Staff including the Head of Trial Co-ordination, Senior Trial Co-ordinator, QA/Project Manager, Financial Administrator and Regulatory Administrator. Various other hospital staff such as radiologists, haematologists and medical secretaries. To ensure that all the information required to update CRF pages such as scan reports, study drug supply, test results and letters regarding any patients on study is available. For some

14 studies the CTC may have to organise tumour samples, copy scans or blood reports to be sent away for independent review. 9. PHYSICAL DEMANDS OF THE JOB Many CRF s are large and cumbersome to move and CTCs have to lift these from high shelves on a daily basis. Space for all these CRF s is very limited. This means that CTCs are often working in an office that has very little workspace. Data for all closed studies is eventually archived off site. This involves shredding all non-essential documentation, condensing the CRF files weighing and lifting heavy boxes. These boxes can weigh up to 15kg. Boxing up documents to have couriered to other sites. These can weigh up to 15kgs and can be couriered up to 10 at a time. CTCs have to spend a large part of their working day using their computer for , data entry, generating / compiling reports and typing up letters. Physical skills using and understanding medical terminology, accurate interpretation of patient data, advanced keyboard/computer use, excellent time management/organisational skills and working quickly and efficiently under pressure. 10. MOST CHALLENGING/DIFFICULT PARTS OF THE JOB Ensuring that you have a highly specialised working knowledge of many study protocols whilst avoiding confusion. This requires allocating time for intense concentration to ensure you have understood all the protocol procedures and requirements. Organising time from day to day dealing with differing demands on your time without falling behind with your overall workload. Dealing with constant interruptions to your working day. Clinicians working on studies only have limited time to spend with the CTC and when they are available, then work has to be stopped. Frequent phone calls from clinicians, other trials co-ordinators and pharmaceutical companies demanding instant answers to their queries. Working with clinicians and making demands on their time without antagonising them. This can mean asking for meetings or speaking to superiors if they do not allocate any time to discuss and review the patients study treatment. Ensuring data is collected accurately from other hospitals. This can be time consuming, telephoning or ing other people. They, in turn, have to take time out

15 from their work to give the relevant reports/operation notes and arrange for either photocopies to be sent or the information faxed. Working under pressure to meet study deadlines as well as dealing with other queries or reporting SAE s for patients on other trials whilst ensuring the quality of the data is maintained. 11. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB Qualifications to degree level or equivalent; Good knowledge of medical terminology; ICH GCP training; Clinical research experience and knowledge of current legislation in the area (eg. EU Directive for Clinical Trials); Excellent organisational skills; Excellent communication skils (oral and written); Excellent IT skills; Ability to work under pressure and ensure deadlines are met; Work on own initiative and as part of a team; Ability to travel nationally and occasionally internationally.

16 NORTH GLASGOW UNIVERSITY HOSPITALS NHS TRUST EMPLOYEE SPECIFICATION JOB TITLE: Clinical Trial Co-ordinator BAND: AfC Band 5 DEPARTMENT/DIRECTORATE: Clinical Trials Unit DIVISION: Regional Services LOCATION: Clinical Trials Unit, The Beatson West of Scotland Cancer Centre CRITERIA ESSENTIAL DESIRABLE QUALIFICATIONS & TRAINING - Computer Literate / Word Processing Experience - Knowledge of Medical Terminology - Educated to degree level - Clinical Research Qualification EXPERIENCE - Previous experience in extracting clinical data - Previous experience of NHS environment - Previous clinical research experience KNOWLEDGE, SKILLS AND ABILITIES - Good organization and communication skills - Aware of confidentiality issues - Ability to organize/prioritize workload - Ability to work unsupervised and as part of a team - Ability to work under pressure PERSONAL QUALITIES - Polite manner - Ability to communicate effectively with staff at all levels in the organization

17 Job title Summary of terms and conditions The terms and conditions of service are those approved and amended from time to time by the National Agenda for Change Terms and Conditions Agreement. Job reference number Clinical Trial Coordinator G Closing date 7 th April 2017 Vacancy enquiries to Agenda for Change band: Band 5 Salary Hours Base Contract type Annual leave Superannuation For information specific to the role, contact: Ruth Orr, ,218 to 28,746 per annum (pro rata where applicable). Please note candidates new to the NHS should expect to start at the entry point of the payscale shown hours per week Beatson West of Scotland Cancer Centre Fixed Term 12 months The basic annual leave entitlement in a full year commencing 1st April to 31st March is 27 Days on appointment, rising to 29 days after five years and 33 days after 10 years. Leave entitlement is pro rata where applicable. All employees are automatically enrolled it the Scottish Public Pensions Agency. Healthcare Support Workers All NHS Scotland postholders that are not governed by a regulatory or professional body are considered to be healthcare support workers. On appointment, you will be expected to comply with the NHS Scotland Mandatory Induction Standards and Code of Conduct for Healthcare Support Workers. Smokefree policy Equal opportunities Healthcare Support Workers are expected at all times to practice competencies that demonstrate insight, understanding and mutual respect of patients, their families, carers and work colleagues. Whether in a clinical or non-clinical role the post holder is expected at all times to be an exemplar of person centred care, embracing their Code of Conduct to a high standard as part of an integrated health professional team. NHS Greater Glasgow and Clyde operates a smokefree policy on all premises and grounds. NHS Greater Glasgow and Clyde is as an equal opportunities employer.

18 The Application Process Please ensure you read the Job Description and Person Specification along with the guidance notes on completing your application form. The hiring manager will shortlist an application for interview based on its content, therefore it is in your best interests to ensure you submit a fully and appropriately completed application. You will receive confirmation that your application submission has been received when you submit your online application form. When we begin to process your application, you will receive an from NHS Greater Glasgow and Clyde confirming receipt. If you have not received a confirmation within 3 days working days from the closing date, please nhsggcrecruitment@nhs.net. Unfortunately, due to the volume of applications NHS Greater Glasgow and Clyde receive, we are unable to write to applicants who are not successfully shortlisted for interview. Accordingly, if you have not received an invitation for interview within six weeks of the closing date please assume on this occasion you have been unsuccessful. We hope this will not deter you from applying again. We will use several methods of communication to advise you of each stage of the recruitment process this includes: , letter, SMS text, or telephone. It is essential that you regularly check your and your phone to see if we have been in contact with you to update you on the progress of your application. Please ensure your account does not treat NHS Greater Glasgow and Clyde as spam or junk by adjusting the necessary settings. Please ensure you retain a copy of the job description and person specification for the post you are applying for you will need this to help you prepare if you are selected for interview. Please retain details of the job reference number you will need this if contacting NHS Greater Glasgow and Clyde Recruitment Services. Should you require further information or assistance in relation to your application please visit or your enquiry to nhsggcrecruitment@nhs.net. Please ensure you have the job reference number to hand. For details on what happens once you have submitted your application, please visit the NHS Greater Glasgow and Clyde recruitment guidance for applicants.

19 Guidance for completing your application form Completion of the application form is the first stage in the recruitment process, and if you are successful, will form the basis of your employment record. Complete and accurate information is essential. Please note: If you knowingly withhold or provide false or misleading information, this may result in your application being rejected, or if appointed, may result in dismissal from your post. Your application form plays a vital role in the recruitment and selection process. The information you provide us with in your application form will be used to decide whether you are shortlisted to attend an interview. Only those applicants who can clearly demonstrate in their application form how they meet the minimum essential requirements for the post as specified in the job description and person specification will be considered for interview selection. Applicants should read the candidate information pack and job description for the post prior to completing the online application form. When completing the online application form applicants should read the instructions in each section and note the following: the application form has an automatic time out mechanisms, therefore you should click on the "save" button as you go through the application form or copy and paste from another document, to avoid losing content. please do not use any special characters (i.e., #, &, %) when completing your application. You are permitted to use symbol. It is recommended that you complete all relevant sections of the application form. It does not matter how long ago your last employment was, if you have an employment history please list it. If you have not previously been employed, please use the Present or Most Recent Post section to detail what you have been doing (i.e. full time student / parent / carer). Please note that you can list unpaid work including work placements and volunteer work in your employment history. NHS Greater Glasgow and Clyde do not accept Curriculum Vitaes (CV), unless a CV has been specifically requested as part of the recruitment process. By completing and submitting an application for this post you give your consent for NHS Greater Glasgow and Clyde to commence pre-employment checks, including reference checks, once your formal conditional offer of employment is made to you. Click Here for more information. For details on NHS Greater Glasgow and Clyde s pre-employment check procedures, please visit the NHS Greater Glasgow and Clyde recruitment guidance for applicants.

20 Part A (Personal information), Part B (Declarations), Part C (Application Details) The job description provides information about the main duties and responsibilities of the post being advertised. It also describes the purpose of the post. Please ensure that your application form clearly demonstrates how your skills / knowledge / experience can be utilised in the role. The job description and person specification also specify the requirements or criteria (knowledge, skills, experience, abilities and qualifications) that are essential or desirable to perform the duties outlined. Please ensure in your application that you demonstrate how you meet the minimum essential criteria and where applicable, the desirable criteria for the role. Certain posts in NHS Scotland are exempt from the 1974 Rehabilitation of Offenders Act (Exclusions & Exceptions) (Scotland) Order Click Here for more information. If the advertisement for this position has declared that we require a Disclosure Scotland PVG Scheme Membership / Disclosure Scotland Check, you must declare any previous convictions, classed as either spent or unspent, including criminal convictions received outside the United Kingdom. The Asylum and Immigration Act 1996 states that it is a criminal offence to employ a person who is not entitled to work in the United Kingdom (UK). Consequently, before NHS Greater Glasgow and Clyde offers employment, the prospective employee must provide evidence, that he/she is entitled to work in the UK. All applicants regardless of nationality will be asked to provide evidence of eligibility to live and work in the UK. As a Disability Confident Employer, NHS Greater Glasgow and Clyde operates a Guarantee Interview Scheme for disabled applicants. Candidates who have declared a disability and who meet the minimum essential criteria outlined within the job description / person specification will be guaranteed an interview. You must provide full and complete employment references including a work address (personal address for employment references may not be acceptable) covering a minimum period of the last three years. Employment referees should be listed in chronological order that is the most recent first. If you have had more than two employers in the last three years we will require additional references. Character referees should only be used in the event that you cannot provide two employer references covering the last three years. Any gaps in employment history must be detailed within your supporting statement and will be explored carefully with you at the interview stage. If you have an employment history of less than three years, you should provide full details of an academic referee or other person who is not a friend, is not related to you or involved in any financial arrangement with you to provide a personal reference.

21 If you have had no previous employment or have been self-employed you should provide details of two personal referees as outlined above and where applicable evidence to confirm your status (i.e. letter from Jobcentre Plus, academic record or evidence from HM Revenue & Customs) if you are shortlisted for interview. Your application form provides you with an opportunity to provide a supporting statement. This section is one of the most important in the application form as the information that is provided here will be evaluated and used to decide if you are invited to attend interview. This section gives you the opportunity to describe and demonstrate the particular qualifications, skills, abilities, knowledge, relevant experience and other qualities that make you a good candidate for the post. Part D (Equal Opportunities) This part of the form is optional and the information you provide in this section exercises no part of the selection process. It is treated in confidence and only the Recruitment Service or Human Resources staff can access this information for the purpose of recording and compliance monitoring, to ensure our workforce is balanced and represents the best candidates from all parts of society regardless of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity status, race, religion or belief, sex, sexual orientation and/or socio-economic status. Data Protection Act 1998 The information you provide on your application will be treated in confidence. Only those NHS Greater Glasgow and Clyde staff involved in the selection process and processing your application will see your application form. If you are the successful applicant your application form will be retained and used to create your employee record file. Your application form will be held for 12 months, from the date of your application, within the NHS Greater Glasgow and Clyde recruitment system, after which period it will be deleted from the system.

22 Working for NHS Greater Glasgow and Clyde About us NHS Greater Glasgow and Clyde is the largest health board and provider of healthcare in Scotland and one of the largest health care providers in the UK. NHS Greater Glasgow and Clyde s purpose is to: Deliver effective and high quality health services, to act to improve the health of our population and to do everything we can to address the wider social determinants of health which cause health inequalities. The Board works in close partnership with other NHS organisations, local authorities and other agencies including the third sector to ensure that social work, education, housing, employment and environmental services unite effectively and efficiently with the NHS in tackling inequalities and underlying health problems in local communities. The future shape of health and social care provision is changing following the move to establish new statutory Partnerships between NHS and Local Authorities, responsible for the planning and delivery of Health and Social care for local populations. This requires the development of very different relationships between primary care, mental health services, community and acute services. NHS GGC serves a population of 1.2 million (over 1/5 of the population of Scotland) with services provided by 39,000 staff. The geographical area covered includes: Glasgow City, West Dunbartonshire, Inverclyde, Renfrewshire, East Renfrewshire, East Dunbartonshire and North Glasgow (Stepps-Moodiesburn corridor). Our services NHS Greater Glasgow and Clyde provides a full range of Secondary and Tertiary Clinical services, Primary Care, Mental Health and Community services included in which are a number of world-class specialist services. Find out more about NHS Greater Glasgow and Clyde at If you want to know more about the NHS Scotland, visit If you are successful in your application to join us, you will be working within one of our Acute, Primary and Community Care Services. These services are in turn supported by a range of Corporate Service functions including Administration, ehealth, Finance, Human Resources, Public Health, Corporate Planning, Facilities and Estates.

23 Click Here to find out more about our Community Services Click Here to find out more about our Mental Health Services Click here to find out more about the services in your area

24 Employee benefits We offer all our staff excellent benefits including; NHS Superannuation pension scheme, Child Care Vouchers, Bursaries to support education and training, Interest free loans to purchase Zonecards for trains, buses, underground and some ferries Cycle to work interest-free loans to purchase bicycles and equipment For more information on the benefits available to NHS Greater Glasgow and Clyde staff, visit Further information For further information on any aspect of the recruitment process or for further details on working within NHS Greater Glasgow and Clyde contact: NHS Greater Glasgow and Clyde Recruitment Services West Glasgow Ambulatory Care Hospital Dalnair Street Glasgow G3 8SJ Tel: +44 (0)