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

Carilion Medical Center•Roanoke, VA

About The Position

Under general supervision of the Principal Investigator, the Clinical Research Coordinator I 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. 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. Recruit, screen, and enroll eligible study participants. Obtain informed consent from study participants. Manages completion and submission of study related documentation. Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. Assist in monitoring enrollment goals. Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team. Collects 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. Tracks and reports adverse events and protocol deviations. Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure. Under supervision, prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence. 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.

Requirements

Bachelor's Degree required.
Bachelor's degree in science or a related field required.
Three (3) years experience in clinical research may be substituted for education.
1 year in healthcare or research preferred.
IATA 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.
Able to work with multiple interruptions and to perform multiple tasks at any given time.

Nice To Haves

1 year in healthcare or research preferred.
Knowledge of medical and/or pharmaceutical terminology strongly desired.

Responsibilities

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.
Recruit, screen, and enroll eligible study participants.
Obtain informed consent from study participants.
Manages completion and submission of study related documentation.
Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
Assist in monitoring enrollment goals.
Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
Collects 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.
Tracks and reports adverse events and protocol deviations.
Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
Under supervision, prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
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.