OVERVIEW: THE CAMPBELL CLINIC FOUNDATION:

The mission of The Campbell Clinic Foundation is to enhance the quality of life for our patients through the science of orthopaedic medicine, with a strong commitment to education, research, and community healthcare. The Campbell Clinic Foundation is affiliated with Campbell Clinic Orthopaedics. Campbell Clinic is a national leader in sports medicine, pediatric orthopaedics, joint replacement, orthopaedic oncology, orthopaedic trauma, physical medicine and rehabilitation, and surgery of the hand, hip, foot, knee, shoulder and spine. The Campbell team is dedicated to sustaining Dr. Willis Campbell’s vision and life’s work of advancing orthopaedics and caring for people in our community and around the globe. The position will be based in Germantown, TN.

POSITION SUMMARY

The Clinical Research Coordinator prepares, submits and monitors documentation of research programs. In addition, the nurse will assure compliance with regulations, protocols, and safety monitoring through process audits. He or she will advise research personnel regarding study design, study procedures, and data abstraction.

Essential Functions Statement(s)

• Prepare IRB ( Institutional Review Board) submissions, proviso resolutions, revisions, and continuing reviews utilizing an in-depth knowledge of human subject protections, protocol requirements, good clinical practices, and regulatory compliance as set forth by federal regulations
• Manage all aspects of conducting investigator - initiated studies, multicenter studies, and industry sponsored trials (maintain essential documents, investigation product accountability, etc.)
• Maintain all data and source documentation, adverse event reporting and maintenance of complete regulatory files
• Review clinical study agreements, protocols and budgets for feasibility and ensure compliance
• Screen, enroll, obtain informed consent, complete study visits, ensure protocol compliance and monitor safety of the subjects enrolled in clinical trials
• Access medical records (including electronic) for research data and assist physicians, residents and students with data abstraction (within IRB guidelines and approvals)
• Enter data into designated electronic platforms from completed source documents for clinical studies per protocol
• Coordinate with principal investigators to provide assistance and education as needed among research personnel, the IRB and the study sponsor (where applicable)
• Coordinate respective subspecialty research meetings, to include the Campbell Foundation Research Committee, and maintain project and submission status of all projects within the Coordinator’s subspecialty
• Maintain strict subject confidentiality for completion of all research records in compliance with Campbell Clinic/Campbell Foundation standards
• Regular and predictable attendance
• Ability to work in a cooperative manner with others
• Perform other duties as required

SKILLS & ABILITIES

Experience: 3 years of experience in a clinical and/or healthcare setting required. 1 year of experience in clinical trials preferred.

Computer Skills: Proficiency in Microsoft applications and basic computer skills required.

Certifications & Licenses: Current RN license in the state of Tennessee preferred. Certification as a clinical research coordinator (CCRC, CCRP) preferred. Basic Life Support (BLS) certification required.

ADA Disclaimer

In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis.

Equal Opportunity Employer/Veterans/Disabled