POSITION DESCRIPTION NAME: POSITION TITLE: Clinical Research Associate DEPARTMENT: DIVISION: REPORTS TO (Sponsoring Physician): DATE CREATED/REVISED: June 19, 2013 POSITION SUMMARY: The Clinical Research Associate works under the direction of investigator(s) to coordinate observational (non-treatment) studies, and provides on-going data management for local and national research studies. May assist Clinical Research Coordinators (CRC) with more complex trials. Assists investigator(s) with preparing documents for IRB and sponsor submissions, screening and recruitment, consenting subjects, preparing adverse event and case report forms, maintenance of research databases, sample procurement and shipping. ESSENTIAL FUNCTIONS: The following describes the basic position duties that an applicant MUST be able to perform for this role. This information is intended to be descriptive of the key responsibilities of the position. The list of essential functions below DOES NOT identify all duties performed by any single person in the position. PLEASE LIST BY ORDER OF IMPORTANCE. Description of Essential Functions of the Position Please estimate the percentage of that is spent on each essential function. This number is meant to be approximate. % Time Be knowledgeable of multiple protocol requirements and visit schedules. Familiar with medical terminology and competent at reviewing medical records. Understand each study s eligibility requirements and assists clinical staff with completing research related tasks. Assists with screening patient records, recruiting patients and obtaining informed consent. Collect and record research data on case report forms and in databases as applicable. Faciliate scheduling of research visits. Assists with development and maintenance of study specific databases as applicable. Assists with obtaining/ maintaining regulatory and institutional approval studies including but not limited to initial submissions, modifications, annual reviews and adverse events reporting, creating forms (consent forms, HIPAA forms, project summaries, etc.), and new research questionnaires for UT Institutional Review Board and Children's Medical Center Research Department. Consults with Children's Medical Center Research Department to facilitate study budgets if indicated. Ongoing oversight of research billing to ensure appropriate research account is charged. 70% 20% Coordinate sample procurement according to protocol. Maintain samples of fluids and/or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. May assist in labeling and storing of blood, urine and other specimens for analysis. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing. OTHER DUTIES and RESPONSIBILITIES: Description of Other Duties and Responsibilities of the Position Requires occasional attendance at out of town professional meetings. Performs other position appropriate duties as required in a competent, professional, courteous manner 10% % Time 2% 5% PATIENT CONTACT: Click on the cell below to see a drop down menu of options of Patient Contact. Direct - Indicates that the person in the position directly provides care, treatment or services to the patient. Ex: Nurses, Physical/Occupational Therapists, RCPs. Revised 6-19-13 ke Page 1 of 6
POSITION REQUIREMENTS: Click on the cells below to see a drop down menu of options for Experience Requirements and Required or Preferred. Minimum Experience: Minimum 1 year of related experience Type of Experience: Please indicate the type of experience that is required/preferred for the position. Clinical research and/or pediatric clinical experience Minimum Formal Education: Four-year Bachelor's degree Type of Degree/Training: Please indicate the type of degree/s or training that is/are required/preferred for the position. Health related sciences Specific Knowledge, Skills and Abilities: Please list the specific skills and abilities that an incumbent must possess to perform the position properly. Knowledge of the Belmont report and Code of Federal Regulations Intermediate to advanced computer skills including a variety of software applications (e.g. spreadsheet and database programs, interactive web based software). Effective, organizational skills and attention to detail; effective follow-through, and commitment to excellence. Effective professional communication skills: Ability to communicate with others in a clear, understandable, and professional manner. Physical and emotional health adequate for attendance requirements and performance, which may include, but is not limited to: assessment of patient conditions, appropriate use of technical equipment, and rapid recognition and response to emergency situations. Maintain compliance with standards for clinical personnel established by Children's. Maintain skills and certifications required by the Research Department. Appearance projects a professional image and engenders the confidence of others. LICENSES and CERTIFICATIONS: Please identify whether certification must be held upon hire or obtained within a designated period. Not Applicable ADDITIONAL NOTES: IATA certification may be required if shipping biological substances (may complete after hire). Patient contact limited to verbal interaction. PROBLEM SOLVING and DECISION MAKING: Click on the cell below to see a drop down menu of options for Problem Solving and Decision Making: Semi-routine - This position may be confronted with multiple choice situations that are similar in nature. Some latitude is given to make choices within parameters. Typically, this is a non-exempt position. Revised 6-19-13 ke Page 2 of 6
WORKING RELATIONSHIPS: List the titles of individuals, departments or organizations, both inside and outside the company, with which the position will have the most frequent contact. Briefly describe the frequency and purpose of those contacts. Click on the cells below to see a drop down menu of options for Contact Frequency. Title Contact Frequency Purpose of Contact Data submission/protocol External study sponsors Weekly requirement questions;query resolution Physicians, fellows, residents, nurses Weekly Serve as information resource in the conduct of clinical research Confirm orders and obtain External/Internal laboratory entities, other hospital departments (pathology, Weekly subject results; negotiate radiology, surgery, ED) special circumstances Coordinate approval for new study initiation, adverse event IRB coordinators / UTSW Administrative personnel Weekly reporting, protocol modification, and continuing review; invicing/payments, contract processing Clinical Research Coodinators, Associates and Staff Daily Coordinate research efforts for new and on-going projects, and provide analysis, training and direction NR3, budget quotes/approvals, Clinical and Program Managers Daily invoice reconciliation, coodinate work load and collaborate projects SUPERVISORY/MANAGERIAL BREADTH: Click on the cell below to see a drop down menu of options for Supervisory/Managerial Breadth. position has no responsibility for the direction or supervision of others but may provide advice/mentoring to an applicant with less experience, skill or tenure; may also be responsible for the direction of volunteers SUPERVISORY RESPONSIBILITY: List the number of incumbents supervised in each category. Indicate the dollar amount of the Operating Budget and Total Base Payroll. Exempt Management: Exempt Non-Management: Non-Exempt Hourly: PRN: Contract: Total: Highest Grade Supervised: FINANCIAL DIMENSIONS: Operating Budget: Total Base Payroll: Fixed or Variable Hours: Fixed Revised 6-19-13 ke Page 3 of 6
PHYSICAL DEMANDS: Click on the cell below to see a drop down menu of options for Physical Strength Demands. Light - Exerting up to 20 lbs. occasionally, 10 lbs. frequently, or negligible amounts constantly and may require walking or standing to a significant degree. Physical Demand For each item, click on the relative Frequency cell to indicate the frequency of each physical demand. Standing Sitting Walking/Moving (from one location to another to perform work) Lifting/Exerting Carrying Pushing/Pulling Reaching Handling Fine Dexterity (skill/adroitness with hands; ex: typing, administering shots, etc.) Kneeling Crouching Twisting Bending Climbing Vision (ability to differentiate between color, to determine distance, depth perception, etc.) Hearing (ability to interpret and differentiate between sound, etc.) Talking (ability to speak coherently and be understood by others) Frequency the the the the more of the more of the more of the more of the Brief Description of Physical Demand Equipment movement, patient care Typing (including patient care documentation), medication preparation and delivery Patient care, equipment use, and computer use Communication by phone and in person with patients and colleagues Communication by phone and in person with patients and colleagues Foot Control (manipulation of pedals, controls, equipment, etc. with feet) Rarely - Less than 1 hour/week Computer, phone, calculator work Revised 6-19-13 ke Page 4 of 6
ENVIRONMENTAL FACTORS: Click on the cell below each heading to see a drop down menu of options of Environmental Factors. Environmental Conditions Working conditions are relatively free from unpleasant environmental conditions. Frequency more of the Brief Description of Working Conditions Stationed in a cubicle setting with desk space, personal computer and telephone. Will spend with patients in hospital or clinics. Health and Safety Concerns Working conditions are relatively free from hazards. Exposure to blood and body fluids Frequently - 1/3-2/3 of the of Work performed at desk and with patients in hospital or clinics. Collection, processing and shipment of biological samples. Office Environment Primary Work Location more of the Office area with greater than 1 cubicle. NON-PHYSICAL DEMANDS: Click on the cell below to see a drop down menu of options of Non-Physical Demands. Non-Physical Demand Time Pressures Person in the position is responsible for producing work/outcomes relatively quickly; within a specified frame. Tedious or exacting work Person in the position is responsible for producing work that is routine and/or repetitious in nature. Frequency more of the more of the Brief Description of Non- Physical Demand Rapid response often required to address patient events, and other projects with critical lines and deliverables Performing complex analysis of research projects/protocols for multiple projects Stress Demands - Person in the position is responsible for maintaining stable performance under pressure or opposition, and handling stress in a manner that is acceptable to others and to the organization. Frequent Change of Tasks Person in the position is responsible for reprioritizing workload based on the needs of the organization. Performing multiple tasks simultaneously - Person in the position is responsible for working on a variety of different tasks simultaneously, while maintaining the quality of the work. of of more of the Handling daily, weekly and monthly pressures related to clinical studies and interactions with various departments and personnel as needed Constantly shifting priorities in response to patient events, department initiatives, and hiring patterns Responding to requests, issues, problems and concerns on multiple projects Emergency Situations Person in the position will be subject to assisting and interacting with people in emergency, stressful, and/or life-threatening situations. Rarely - Less than 1 hour/week May assist or manage situations that are emergent, stressful and/or life-threatening Variable Schedule/Over Person in the position is required to work evenings and/or weekends, or is required to work over. of Meetings and assignements may require attendance outside regular work days and hours The above statements are intended to describe the general nature and level of work being performed by applicants assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties and skills required. This position description is subject to modification. Revised 6-19-13 ke Page 5 of 6
SIGNATURE AND APPROVAL: I have reviewed this position description, I understand it, and I find it to be an accurate representation of the demands of the position. Applicant: Primary Sponsoring Physician: FOR HOSPITAL USE ONLY: All clinical research protocols must be signed by the Director of Clinical Research: Recommended Not Recommended Recommended with the following modification(s) and reason(s): Clinical Manager, Research: Shirley Montanye Director, Research Adminstration: Deborah Town - Interim Leader Revised 6-19-13 ke Page 6 of 6