Clinical Research Coordinator - Grant Funded - Department of Medicine Clinical Research Unit

About the position Under general supervision of the Principal Investigator, assists with administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. Responsibilities include recruiting, screening, and enrolling eligible study participants, obtaining informed consent from study participants, managing completion and submission of study related documentation, and communicating with research sponsors or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. The coordinator will assist in monitoring enrollment goals, coordinate tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team. Data collection from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources is also required. The role includes collecting, processing, and shipping research specimens as directed in the protocol, ensuring compliance with study protocol and requirements of regulatory agencies, tracking and reporting adverse events and protocol deviations, and coordinating all site related monitoring or auditing visits from sponsors or federal agencies during the course of the study and at closure. Under supervision, the coordinator prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence, and develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log.

Responsibilities

• Assist with administrative activities associated with the conduct of research studies.
• Recruit, screen, and enroll eligible study participants.
• Obtain informed consent from study participants.
• Manage completion and submission of study related documentation.
• Communicate with research sponsors or CRO, local or central IRB, Research and Development, and other ancillary departments.
• Assist in monitoring enrollment goals.
• Coordinate tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Collect, process, and ship research specimens as directed in the protocol.
• Ensure compliance with study protocol and requirements of regulatory agencies.
• Track and report adverse events and protocol deviations.
• Coordinate all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
• Prepare, submit, and maintain IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
• Develop and maintain patient databases and study maintenance logs.

Requirements

• Bachelor's Degree required, preferably in Science or a related field.
• 1 year in healthcare or research preferred.
• IATA certification required with hire.
• Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment.
• Knowledge of medical and/or pharmaceutical terminology strongly desired.
• Strong organization and communication skills required.
• Ability to work with multiple interruptions and to perform multiple tasks at any given time.

Benefits

• Employer Funded Pension Plan, vested after five years (Voluntary 403B)
• Comprehensive Medical, Dental, & Vision Benefits
• Flexible Work Arrangements/Schedules
• Remote Work Options
• Paid Time Off (accrued from day one)
• Onsite fitness studios and discounts to our Carilion Wellness centers
• Access to our health and wellness app, Virgin Pulse
• Discounts on childcare
• Continued education and training

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