Clinical Research Coordinator II, Health Services Research

How You’ll Help Transform Healthcare:

Under minimal supervision of the Principal Investigator, assists with the administration of Health Services Research studies from conception to completion while maintaining compliance with guidelines set by governing agencies and institutional policy.

• Obtain informed consent from study participants. 
• 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 recruitment efforts and 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.  
• 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.

• Conducts quantitative and qualitative study procedures, with training and supervision.

• Efficiently uses Microsoft Excel to construct and clean datasets. Performs basic statistical analyses, with supervision.
• Formats scientific manuscripts for publication and posters/slides for presentations.

What We Require:

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

Experience: Master's Degree or three (3) years in healthcare or research preferred. Demonstrated proficiency in above responsibilities may be accepted in lieu of years of experience for new hires and career ladder advancement. Experience with REDCAP, survey tools, statistical software preferred.

Licensure, certification, and/or registration: CITI/IRB and COI training required immediately upon 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. Ability to maintain confidentiality and ethical requirements of research protocols.

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.