Clinical Research Coordinator - Grant Funded - Cardiology

Carilion Clinic•Roanoke, VA

18h•Onsite

About The Position

The Clinical Research Coordinator will support clinical trials in the Department of Cardiology at Carilion Clinic. 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 the Department of Medicine Clinical Research Unit, this position is charged with maintaining compliance with study protocols, guidelines set by governing agencies, and institutional policy. Clinical Research Coordinator career ladder placement at hire ranges from level I-IV based on experience, certification, and education. Advancement opportunities are available based on experience, certification, education, and competency level. Candidates Should Possess the Following Qualities: Detail-oriented Organized Comfortable in a fast-paced environment Able to balance multiple priorities Motivated by challenges Compassionate towards patients and their families/caregivers Under minimal 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. Demonstrated competency managing complex studies. Able to provide basic skills training for CRC Is and Clinical Research Assistants.

Requirements

Bachelor's degree in biology or medical/clinical sciences or a related field required. Four (4) years of experience in clinical research may be substituted for education.
3 years in healthcare or research.
Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required within 12 months of hire.
I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
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.

Responsibilities

Assist 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.
Demonstrated competency managing complex studies.
Able to provide basic skills training for CRC Is and Clinical Research Assistants.