Clinical Translational Research Coordinator II - ON SITE

Discover Vanderbilt University Medical Center:  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

Orthopaedic Surgery & Rehab

Job Summary:

This is a full-time position in the Department of Orthopaedic Surgery, Kristin Archer, PhD, Principal investigator. A coordinator with at least 1 year (preferably 2-5 years) of clinical research is needed on the team to support multi-center randomized clinical trials funded by the Department of Defense (DoD). The coordinator will enroll and follow study subjects undergoing spine surgery at VUMC and will assure compliance with the study protocols. Responsibilities will include maintaining and updating study protocol; overseeing IRB initial submission, amendments, and continuing review; recruitment and follow-up of patients; ongoing communication with the PI, spine surgeons and rehabilitation providers to ensure adherence to study protocols; and overseeing weekly meetings with the PI, co-investigators, and study staff to report on study progress.

Key Functions and Expected Performances:
• Maintain accurate and timely documentation of study procedures and communication with investigators and federal sponsors
• Maintain IRB documentation and ensure research is conducted in accordance with Good Clinical Practice Guidelines and sponsor guidelines
• Recruit appropriate individuals for study participation according to study protocol which involves medical chart review and patient screening or interviewing
• Enroll eligible study participants
• Complete assessment procedures with study participants in clinic or remotely
• Schedule participants for initial and/or follow-up appointments
• Conduct follow-up calls, emails, or mailings related to study activities
• Communicate regularly and effectively with investigators and other members of the research team on an ongoing basis related to study protocol.
• Maintain study database
• Attend weekly research team meetings
• Contribute to a positive work environment

REQUIRED:
- Bachelor's Degree (or equivalent experience)
- Minimum 1 year of relevant experience; 2-5 years preferred
- Ongoing access to reliable transportation
- Experience in REDCap is a plus

This position will work traditional, daytime business hours Monday-Friday.

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DEPARTMENT SUMMARY:

In the Department of Orthopaedic Surgery at VUMC, each year we provide 110,000 outpatient visits and manage 11,500 surgical cases — all with a passion for equipping the next generation of orthopaedic surgeons and for making a difference in the lives of the people we serve. For additional information, please visit https://www.vumc.org/ortho.

KEY RESPONSIBILITIES

• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation