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Job Code: 1946
Job Level: 81
Revised Date: 12/01/2007
Job Family: JF 05

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Occupational Summary

Develop and implement research and administrative strategies essential to the successful management of clinical trials research conducted by principal investigators at Duke University Medical Center; assist the Clinical Trials Manager in supervising work of other Clinical Trials Coordinators and perform a variety of duties involved in standardization of operating procedures across all trials.

Work Performed

Supervise and coordinate assigned multi site or global scale clinical trials research studies conducted by principal investigators in support of activities that meet objectives of assigned research protocols.

Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols.

Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration 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 trials sites and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's 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.

Prepare and recommend 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); supervise clinical trials assistants and/or contracting agents in the receipt and dissemination of study materials.

Supervise work of clinical trials coordinators and 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


Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three years of 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 five years healthcare experience; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**


None required beyond that described above.




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.