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CLINICAL TRIALS COORDINATOR I
Job Title: CLINICAL TRIALS COORDINATOR I
Job Code: 1941
FLSA: E
Job Level: 79
Revised Date: 08/01/2021
Job Family: JF 05
Occupational Summary
Participate in the development, coordination and implementation of research and administrative strategies essential to the successful management of clinical trials research conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data.
Work Performed
Participate in the coordination of multi site or large scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
Follow established guidelines in the collection of clinical data and/or administration of clinical trials.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
Draft a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trials progress.
Assist principal investigator(s) and/or other members of the research team in the development of plans and protocols for clinical research studies; contribute to the ongoing analysis and modification of protocols as appropriate.
Assist in the preparation and recommendation of amendments to clinical trials protocol(s) in conjunction with appropriate committees.
Ensure distribution of appropriate forms, supplies, equipment, laboratory samples and drugs required for execution of research protocol (s); oversee clinical trials assistant and/or contracting agents in the receipt and dissemination of study materials.
Review work of clinical trials assistants within designated areas and assist in training new personnel; inspect study files to ensure completeness and accuracy of data.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus one year healthcare experience, or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or Associates degree(non-specified) plus a minimum of four years closely related clinical research; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with no additional experience; or 3. Completion of a Bachelor's degree plus a minimum of one year directly related clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of two years closely related research experience.
**State of North Carolina licensure may be required**
Experience
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
N/A
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
