CLINICAL TRIALS COORDINATOR II

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary

Develop, coordinate and implement research and administrative strategies essential to the successful management of clinical registry research conducted by principal investigator(s) in the Outcomes group at the DCRI; perform a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data, including, but not limited to, writing study processes, preparing reports, and running and reconciling queries.

 
Work Performed

Coordinate assigned multi-site or large-scale clinical registry research studies conducted by an Outcomes principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).

Assist in developing guidelines for clinical registry data collection and/or in the administration of new projects; assist in the determination of guidelines for new protocols.

Confer with site coordinators and physicians to explain protocol, definitions, and data entry mechanisms and to elicit compliance with regulations; identify potential problems and/or inconsistencies and take action as appropriate.

Draft a variety of reports, documents and correspondence for sponsors, participating clinical trial sites and for internal purposes to assist in the ongoing monitoring and evaluation of the registry progress.

Assist principal investigator(s) and/or other members of the research team in the development of plans and protocols for clinical registries; contribute to the ongoing analysis and modification of protocols as appropriate.

Prepare and recommend amendments to clinical registry protocol(s) in conjunction with appropriate project committees; oversee clinical trials assistant and/or contracting agents in the receipt and dissemination of study materials. Supervise 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 Outcomes Clinical Trial Coordinator IIs. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Required 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 a minimum of two years healthcare experience, or one of the following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) 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 a minimum of one year directly related clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of three years directly related 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 licensure may be required**

** NOTE: This position may have an opportunity to work remotely.  All Duke University and Duke Health remote workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

Experience

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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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 essentialjob 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.