DCI's Clinical Research Coordinators provide support, coordination and leadership for drug/device studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials; government-funded clinical research, and investigator-initiated clinical research (collectively referred to as “clinical research involving human subjects”). They ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure. They prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, schedule clinical treatment and follow-up care, and facilitate patient’s continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents, and ensure compliance with study protocols in order to provide consistent and quality data. Provide superior healthcare utilizing medical knowledge and clinical skills throughout each clinical trial.
- Ensure compliance with the clinical trial protocol and overall objectives of the study including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board (IRB) applications, CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture, etc.) as applicable.
- Perform detailed medical chart review and patient interview to ensure patient qualifies to be enrolled in the study.
- Manage informed consent process and ensure confidentiality practices are consistent with regulatory and study guidelines.
- Maintain a strong relationship with subjects involved in clinical trials and ensure that their rights as subjects are protected.
- Meet enrollment goals as directed by Research Director.
- Coordinate and perform study visits/procedures (vital signs, EKG's, BIA, medical history, lab procedures, etc.) per qualification and per protocol.
- Log and inform Principle Investigator (PI) of any possible adverse reactions or serious adverse events in a timely manner.
- Maintain study logs, IRB forms and Regulatory Binders for each clinical trial.
- Maintain a strong relationship with and be available to investigators and research, dialysis, and practice staff to ensure subject safety and compliance with the clinical trial protocol.
- Conduct clinical trials in 2 or more outpatient dialysis units as needed.
- Coordinate multiple trials.
- Work independently with limited supervision.
- Requires 3 years of relevant experience conducting clinical trials.
- A Registered Nurse, Registered Dietitian, or an LPN with 3 years of dialysis experience will also be considered.
DCI is a federal contractor and an Equal Opportunity/Affirmative Action Employer-Veterans/Individuals with Disabilities. If you are having difficulty using the online application system or would like to request other accommodations or application methods, please contact Doug Patterson at Accommodations@dciinc.org or 615-327-3061. Once a request has been made, DCI will initiate a discussion with you about your needs and whether an accommodation can be provided. DCI is committed to providing such accommodations where possible.
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