Concentric Methods is seeking a Clinical Protocol Coordinator to join our ream in Bethesda, MD in support of the NIH.

Responsibilities:

• Manage clinical protocols by training the study personnel; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence
• Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance
• Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, and overseeing study visits
• Obtain and document informed consent of participants
• Assess acute and non-acute clinical and research related problems and toxicities, communicate to physicians and report adverse events per protocol to sponsor and IRB
• Perform clinical and research-related procedures, including (but not limited to) patient scheduling; obtaining medical and family history; administering questionnaires
• Monitor and document clinical and research-related developments and response to therapy and communicate findings to principle investigators with recommendations for appropriate intervention
• Complete case report forms as per protocol (reports in NIH documentation system and to sponsor)
• Assist nurse practitioners and physicians with specialized procedures and diagnostic examinations
• Observe and ensure the safety of human subjects while procedures are being performed
• Collect and ensure that sample volumes collected are within protocol, and ensure all samples are properly shipped
• Abstract medical information from medical history, medications and preexisting conditions for new participants
• Receive patient phone calls, furnish the requested information, or refer callers to the appropriate staff members
• Obtain medical records from primary care physicians and review medical records for enrollment eligibility. Review and prepare participant charts and record lab results for all new enrollments
• Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study
• Supervise and coordinate the collection, processing, shipment and storage of biospecimens
• Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations

• Position requires current licensure to practice as a registered nurse in the state of Maryland

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