CLINICAL RESEARCH ANALYST
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational SummaryCoordinate implementation, refinement and improvement DOCR’s portion of the Clinical Research Institutional Approval process. Review study documents to determine ClinicalTrials.gov requirements and provide support to study teams with using the Protocol Registration and Results System. Collaborate with teams internal and external to DOCR to assess study readiness prior to go-live. Demonstrate an understanding of institutional requirements for OnCore and provide end user support to promote accurate use of the application.Work PerformedReview protocols and issue Institutional approval. Monitor critical pathways to avoid delays in the clinical research workflow. Show a clear understanding of the research operations and financial workflows for clinical research in OnCore. Provide support to end users with these workflows.Review OnCore reports on a regular basis and help study teams address inconsistencies and update information as needed.Field questions from the research community about OnCore, ClinicalTrials.gov and the DOCR review process. Assist in planning in-services and developing training materials.Review reports on a regular basis to identify potential compliance concerns in ClinicalTrials.gov. Assist study teams with addressing these issues in the PRS.Assist study teams with entering registration and results information in ClinicalTrials.gov. Maintain a database for tracking compliance with clinical trials disclosure regulations and policies.Required Qualifications Education/Training: Work requires one of the following:Work requires graduation from an accredited degree program in a clinical field such as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two 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 clinical and/or research experience; or2. Completion of a bachelor's degree in a field related to health science and a minimum of three clinical and/or research experience.
None required beyond that described aboveOR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Work requires graduation from an accredited degree program in a clinical field such as a Registered Nurse (RN), Physicians Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents: Completion of an allied health degree (e.g., Respiratory Therapy, Radialogic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years clinical and/or research experience. Completion of a bachelors degree in a field related to health science and a minimum of three clinical and/or research 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.