Clincal Research Coordinator - Adult Respiratory Therapy
Duke University Health System · Durham, NC · 2 wk ago
AnalystFull-time
Pursue your passion
The Clinical Research Coordinator will work at Duke University Hospital in Durham, North Carolina, part of the largest of four Duke Health hospitals with 1062 patient beds. Duke University Hospital is consistently ranked among the best in the United States.
How you will make an impact
- Coordinate and participate in clinical research studies conducted by principal investigator(s) at Duke University Medical Center.
- Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
- Avoid compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies.
- Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees and Duke Institutional Review board, maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CV’s, licenses, site laboratory certifications) coordinate Human Protections Training for personnel.
- Perform regulatory audits on cooperative group, industry sponsored, and Duke Investigator Initiated protocols at clinical and affiliate sites, and submit findings and recommendations in writing.
- Develop work plans to address findings.
- Lead regulatory educational events for regulatory personnel.
- Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate.
- Provide guidance to lower-level personnel involved in planning, implementation and evaluation of clinical studies.
- Assist in training new personnel.
- Perform other related duties incidental to the work described herein.
Education
- Work requires graduation from an accredited degree program in a clinical field such as a BSN, Physician's 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, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare, clinical and/or research experience;
- Completion of a bachelor's degree in a field related to health science plus a minimum of three years closely related clinical and/or research experience.
- N/A