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.
The Clinical Research Coordinator will support clinical trials at Carilion Clinic in the Department of Cardiology. Basic responsibilities include supporting research investigators/physicians with guidance on research policies and processes, enabling successful collaborations with research sponsors, monitoring and tracking study progress, study design assistance, regulatory submission and maintenance, research subject visit management, and any other research-related duties, as necessary. Under the supervision of Research and Development, this position is charged with maintaining compliance with study protocols, guidelines set by governing agencies, and institutional policy. Career ladder opportunities are available based on experience, certification, and education.
Candidates Should Possess the Following Qualities:
Comfortable in a fast-paced environment
Able to balance multiple priorities
Motivated by challenges
Compassionate towards patients and their families/caregivers
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.
What We Require:
Education: 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.
Experience: 1 year in healthcare or research preferred.
Licensure, certification, and/or registration:
IATA required with hire.
Other Minimum Qualifications: 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.
This is Carilion Clinic ...
An organization where innovation happens, collaboration is expected and ideas are valued. A not-for-profit, mission-driven health system built on progress and partnerships. A courageous team that is always learning, never discouraged and forever curious.
Headquartered in Roanoke, Va., you will find a robust system of award winning hospitals, Level 1 and 3 trauma centers, Level 3 NICU, Institute of Orthopedics and Neurosciences, multi-specialty physician practices, and The Virginia Tech Carilion School of Medicine and Research Institute.
Carilion is where you can make your own path, make new discoveries and, most importantly, make a difference. Here, in a place where the air is clean, people are kind and life is good. Make your tomorrow with us.