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

How You’ll Help Transform Healthcare:

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.

What We Require:

Education: Bachelor's Degree in Biology or Medical/Clinical Sciences or a related field required. Four (4) years experience in clinical research may be substituted for education.

Experience: 3 year in healthcare or research.

Licensure, certification, and/or registration: 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.

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.

About Carilion

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.

 

Requisition Number: 154601
Employment Status: Full time
Location: CASB - Carilion Administrative Services Building
Shift: Variable Hours
Shift Details: General Monday-Friday 8:00am-5:00pm and some weekends
Recruiter: HAYLEY F OHL
Recruiter Email: [email protected]
For more information, contact the HR Service Center at 1-800-599-2537.

Carilion Clinic is an Equal Opportunity Employer: We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age (40 or older), disability, genetic information, or veterans status.
Carilion Clinic is a drug-free workplace.