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How Youll 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: Bachelors 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.

Experience: 3 years 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.

This job description is only meant to be a representative summary of the major responsibilities and accountabilities performed by the incumbents of this job. The incumbents may be requested to perform job-related tasks other than those stated in this description.

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For more information contact the HR Service Center at 1-.

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 is a Drug-Free Workplace. For more information or for individuals with disabilities needing special assistance with our online application process contact Carilion HR Service Center at 8:00 a.m. to 4:30 p.m. Monday through Friday.

For more information on E-Verify: Pay and Well-beingat Carilion Clinic

Carilion understands the importance of prioritizing your well-being to help you develop and thrive. Thats why we offer a well-rounded benefits package and many perks and well-being resources to help you live a happy healthy life at work and when youre away.

When you make your tomorrow with us well enhance your potential to realize the best in are benefits available to you when you join Carilion:

• Comprehensive Medical Dental & Vision Benefits
• Employer Funded Pension Plan vested after five years (Voluntary 403B)
• Paid Time Off (accrued from day one)
• Onsite fitness studios and discounts to our Carilion Wellness centers
• Access to our health and wellness app Virgin Pulse
• Discounts on childcare
• Continued education and training