Clinic Trial Coordinator

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1 Date: February 2016 Job Title : Clinic Trial Coordinator Department : Haematology Location : North Shore & Waitakere Hospital Reporting To : Operationally to: Operations Manager Haematology Professionally to: Manager Awhina Research, Innovation & Knowledge/ Nurse Consultant (Research) and Clinical Nurse Specialist- Haematology Research Direct Reports : Nil Functional Relationships with : Internal Haematology patients Haematology staff Research office Other departments External Collaborative trial groups Pharmaceutical companies Contract research organisations Ethics committees External suppliers Committees/groups Research team Awhina Knowledge & Research NZACRes Our Purpose, Values and Standards At the heart of Waitemata DHB is our promise of better care for everyone. This promise statement is the articulation of our three-fold purpose to: 1. promote wellness, 2. prevent, cure and ameliorate ill health and 3. relieve the suffering of those entrusted to our care. At the heart of our values is the need for all of us to reflect on the intrinsic dignity of every single person that enters our care. It is a privilege to be able to care for patients, whānau and our community, a privilege that is sometimes overlooked in our day to day work. Our standards and behaviours serve as a reminder to us all about how we are with our patients and with each other. Waitemata District Health Board -JOB DESCRIPTION - Page 1

2 Purpose of the role : To ensure the effective and ethical management of multiple clinical trials according to good clinical practice standards. KEY TASKS EXPECTED OUTCOMES Co-ordination of clinical trial projects Understands the objectives of the research project undertaken. Assists with the development and implementation of the contractual requirements by liaison with legal advisors, DHB management, local and international sponsor/trial company representatives, regulatory committees and external agencies. Assist with preparation, submission and ongoing requirements of Ethics Committee applications and approval processes. Liaises with Maori Research Advisory group regarding research protocol in relation to the principles of the Treaty of Waitangi. Assists with the co-ordination of the necessary investigations required of trial protocols. Ensures data management is to a high standard and completed in a timely manner. Is responsible for monitoring and ensuring compliance to trial protocol and regulatory committee guidelines. Adheres to informed consent principles. Works within the budget limitations of the study. Screening, recruitment and follow up of patients for individual trails Maintains high professional standards according to international and national standards according to Good Clinical Research Practice guidelines. To screen potential trial patients for eligibility To successfully recruit and randomize/register patients meeting eligibility To establish/maintain procedures or process to effectively collect the required data for each trial To maintain patient visit, treatment and investigation schedules as per protocol To maintain up to date CRF s for each active study To resolve data queries in a timely manner Waitemata District Health Board -JOB DESCRIPTION - Page 2

3 Demonstrates Clinical Effectiveness Finance and Administration Uses nursing skills to assess, plan and implement clinical trial protocols. Co-ordinates and implements all necessary investigations required of the studies including clinical assessments, diagnostic test ordering and result interpretation, phone triage and liaison with key study and medical personnel. Responsible for collection and dispatch of samples from research trial participants and manages this in a timely manner according to IATA Dangerous Goods Regulations. Collaborates with interdisciplinary team to coordinate manage care for best health outcomes. Ensures documentation is of a high standard. To manage workflow and workload to meet deadlines To close and archive completed studies Assist with account management for each trial: invoicing, payments, reporting Alert Team Leader to issues or substantial changes in trial status that affect income and outgoings Identify and implement ways to improve trial income or reduce trial costs. Continuing Education Attend GCP certification training To contribute to professional development with the team To attend or present at one identified national or international conference/meeting each year Complete the online training at on protecting human research participants Attend education and information session held at DHB relevant to clinical Present or organize ongoing education for the team Identify self-learning needs and initiate selflearning. Waitemata District Health Board -JOB DESCRIPTION - Page 3

4 Participant/client protection Recognises the importance of acknowledging the context in which clinical research is undertaken Ensures the initial and ongoing informed consent process Supports participant/client in defining his/her reasons and goals for participating in clinical research Acts as the primary research team contact for clinical trial participants and their families. Advocates for participant/client and accesses resources (where appropriate and agreed) Collaborates with the interdisciplinary team to ensure best practice and ethical compliance Coordinates research activities to minimise participant/client risk Maintains participant/client privacy and confidentiality of data Professional Conduct Form and maintain effective working relationships with the DHB and external groups KEY ACCOUNTABILITES Treat peers, colleagues and external parties with dignity and respect Actively work together to deliver beyond expectations. Take ownership and accountability and display energy, initiative and follow through to achieve gals and meet targets. Communicate effectively with internal and external parties. Actively listen, identify needs and share views and information to build trust and deliver results Identify, implement and share processes that enhance the potential of the team to deliver excellence. EXPECTED OUTCOMES Quality Standards Quality standards are documented, communicated and monitored. All trials are conducted according to good clinical research practice standards. Organisation Workload/flow is managed to achieve goals, recognizing and addressing barriers as well as taking account of changing priorities. Systems administration Systems are administered effectively and efficiently, ensuring timely and accurate reporting Waitemata District Health Board -JOB DESCRIPTION - Page 4

5 of clinical data and fulfilment of required regulatory processes. Communication Communication with patients, colleagues and other people who interact with the service is professional and appropriate. Professional Development Responsibility and accountability for own work practice is demonstrated. Appropriate learning activities are undertaken. Critical Competencies Quality orientation Requires particular attention to detail and initiation of self-checking procedures, ensuring high levels of accuracy and consistent quality of data. Understands good clinical practice standards for conducting clinical trials. Monitors quality and devises systems to support continuous improvement, implementing corrective procedures where required. Organizing Manages workload/flow for multiple projects simultaneously, recognise and addresses barriers, and takes account of changing priorities. Most deadlines are determined by external circumstances and must be met. Analytical Ability Breaks complex information down logically to identify key aspects, casual factors and links between information from difference sources, resolving any inconsistencies identified. Judgement/decisiveness The clinical trial coordinator considers and develops options, identifies pros and cons, and makes effective decisions within appropriate times frames and levels of responsibility. Recognises critical factors and weighs up risks appropriately. Knows when to ask for help. Teamwork Collaborates with fellow research team members, clinicians, nurses and representatives of collaborative trial groups, drug companies or contract research organisation, research development office and Ministry of Health to achieve objectives. Actively contributes to and accepts consensus decisions and seeks out opportunities to support others in achieving goals Effective communication Expresses information effectively, orally and in writing, adjusting language and style to recipients, and considering their timeframe of reference. Waitemata District Health Board -JOB DESCRIPTION - Page 5

6 Communicates and consults effectively with patients and colleagues from diverse backgrounds. Recognises and respects individual differences. Actively listens, drawing out information and checking understanding. Empathises with others and considers their needs and feelings. Patient orientation Develops positive working relationships with patients, identifies and seeks to meet their needs. Treats them as first priority and improves service. Maintains confidentiality of patient information. Self-management Sets high standards and strives to achieve stretching goals. Displays drive and energy and persists in overcoming obstacles. Copes with stress, is resilient to change and understands person limitations. Knows when to ask for help. Is proactive and displays initiative. Learning Constantly strives to build clinical knowledge and research skills, acknowledges and learns from mistakes and improves outcomes. Participates in appropriate training courses and attends scientific meetings where required. Computing Is able to use standard software applications (NS Office Suite, MS Access) to undertake complex tasks. The role requires preparation of letters, ethics applications, protocol summaries, treatment instructions for clinicians, information sheets for patients as well as other trial documentation, Power Point presentations and excel spreadsheet s Statutory & Treaty of Waitangi obligations Ensures the professional and political integrity of WDHB by carrying out all functions in compliance of the Treaty of Waitangi and by demonstrating a serious commitment to keeping the treaty alive. Shows sensitivity to cultural complexity in the workforce and patient population To recognise individual responsibility for workplace Health & Safety under the Health & Safety Act 1992 & Amendments 2002 Support WDHB H&S Culture by: All Employees Following & complying with H&S policies & processes & applying them to their own work activities Identifying, reporting & self-managing hazards where appropriate Early and accurate reporting of incidents at work Waitemata District Health Board -JOB DESCRIPTION - Page 6

7 Waitemata District Health Board -JOB DESCRIPTION - Page 7

8 PERSON SPECIFICATION POSITION TITLE: Clinical Trial Coordinator Minimum Preferred Experience & Knowledge Tertiary qualification Minimum 3 years recent experience in tertiary health sector Well-developed computer skills (specifically Word & Excel) Advanced problem solving abilities Background in clinical trials research Knowledge of current good clinical practice guidelines Knowledge of haematology procedures Nursing Haematology background Access skills Personal Qualities Strong communication skills Focus on attention to detail Organisational skills Time-management skills Ability to work autonomously with minimal supervision. Project management skills Waitemata District Health Board -JOB DESCRIPTION - Page 8

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