Clinical Research Coordinator, Full-Time 40 Hours

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 (CRC) prepares, submits and monitors documentation of research studies. In addition, the Clinical Research Coordinator will assure compliance with local and federal regulations, protocols, and safety monitoring through process audits. He or she will advise research personnel regarding study design, study procedures, data abstraction and data storage. The CRC supports, facilitates and coordinates daily research activities and plays a critical role in the conduct of the studies.

This position is full-time, 40 hours per week.

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 local and 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 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 studies

• 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 per study protocol from completed source documents

• Coordinate and communicate with principal investigators to provide assistance and education as needed among internal and external study partners

• Coordinate respective subspecialty research meetings, to include the Campbell Foundation Research Committee, and maintain project and submission status of all projects within the Clinical Research Coordinator's subspecialty

• Maintain strict subject confidentiality of all research records in compliance with Campbell Clinic/Campbell Foundation standards

• Facilitate data analysis and assist with oral and written presentation materials as required

• Regular and predictable attendance

• Ability to work in a cooperative manner with others

• Fluent in oral and written English

• 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.

Education: Bachelor's Degree required.

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.

Campbell Clinic Benefit Summary:

Campbell Clinic offers a lucrative benefit package to support employees and their families.

• Medical / Dental / Vision Insurance

• HRA Option

• Flexible Spending Account

• Basic Life Insurance

• Voluntary Life Insurance Option

• Long-Term Disability

• Voluntary Short-Term Disability

• Accident Insurance

• Critical Illness Insurance

• 401(k) Plan Matching + Profit Sharing

• Employee Assistance Program

• Paid Time Off

• 8 Paid Holidays

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