Campbell Clinic Foundation · 1 day ago
Clinical Research Coordinator
Foundation Germantown, Germantown, TN, US
Full-time
Onsite
Entry, Mid Level
2+ years expCampbell Clinic Foundation is dedicated to advancing orthopedic medicine and patient care through impactful research. The Clinical Research Coordinator (CRC) will coordinate clinical research studies, facilitate patient participation, and ensure compliance with regulations while collaborating with internal teams and external partners.
Health CareHealth DiagnosticsHospital
Responsibilities
Prepare IRB (Institutional Review Board) submissions, proviso resolutions, revisions, and continuing reviews utilizing 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, monitor visit oversight, etc.)
Maintain all data and source documentation, adverse event reporting, and essential regulatory files
Review clinical study agreements, protocols, and budgets for feasibility and ensure compliance
Apply Good Clinical Practice (GCP) guidelines and principles of Human Subjects Protection in study conduct to include the screening, recruitment, consent, study visit completion and safety monitoring
Access medical records (including electronic) for research data and assist physicians, residents, and students with data abstraction (within IRB approvals)
Enter data into designated electronic platforms per study protocol from completed source documents
Coordinate and communicate with principal investigators and the research team to provide assistance and education as needed among internal and external study partners
Participate in and lead respective subspecialty research meetings, including the Campbell Foundation Research Committee, and maintain project and submission status of all projects within the CRC’s subspecialty
Stay calm and focused with a large volume of work and against pressing deadlines
Successfully meets deadlines, works independently, is innovative and proactive in solving problems, and learns and uses medical terminology
Builds rapport and trust with prospective subjects, potential subjects, research personnel, and partners
Maintain strict subject confidentiality of all research records in compliance with Campbell Clinic/Campbell Foundation standards and federal laws
Facilitates data collection and analysis and provides study progress updates as indicated
Assist with the preparation of oral and written presentation materials as indicated
Regular and predictable attendance
Ability to work cooperatively with others
Fluent in oral and written English and speaks in a manner easily understood by the patient population
Perform other duties as required
Qualification
Required
2 years of experience in a clinical and/or healthcare setting
1 year of experience in clinical trials
Bachelor's Degree
Able to communicate effectively in the English language
Proficiency with word processing, spreadsheets, and electronic data capture systems
Basic arithmetic skills
Identifies and resolves problems promptly
Familiarity with medical terminology and medical codes
Preferred
A current RN license in the state of Tennessee
Certification as a clinical research coordinator (CCRC, CCRP)
Basic Life Support (BLS) certification
Knowledge of federal regulations governing research to include but not limited to 21 CFR 50 and 45 CFR 46
Knowledge of orthopaedic pathology and surgery
Benefits
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
Company
Campbell Clinic Foundation
Campbell Clinic Foundation provides orthopaedic research and patient care services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase