Clinical Research Coordinator

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. What You Can Expect We offer the opportunity to pursue your passion for caring at Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of the four Duke Health hospitals with 1,062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more. How You Will Make An Impact The Clinical Research Coordinator will coordinate and participate in clinical research studies conducted by principal investigator(s) at Duke University Medical Center. You will coordinate complex activities involved in the collection, compilation, documentation and analysis of clinical research data. You will also coordinate and perform study‑specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, SOPs, and study‑specific protocols/plan and processes. Clinical: Coordinate and participate in clinical research studies conducted by principal investigators 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. Assist in the determination of guidelines for the collection of clinical data and/or administration of clinical studies. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate. Evaluate and interpret collected clinical data in conjunction with principal investigators as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Confer with principal investigators to assist in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication. Coordinate the development of forms, questionnaires and the application of research techniques; assist in writing procedure manuals for data collection and coding. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Regulatory: Assure compliance of general and study‑specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study‑specific processes. 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. Work closely with sponsor and study personnel on relevant regulatory issues. Develop policies and procedures pertaining to regulatory processes. Lead regulatory educational events for regulatory personnel. All: 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 Associate’s degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare, clinical and/or research experience; or 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. What You Will Need None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Degrees, Licensures, Certifications N/A Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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. #J-18808-Ljbffr