Clinical Research Coordinator

Campbell Clinic•Germantown, TN

41d

About The Position

The Campbell Clinic Foundation Clinical Research Coordinator (CRC) plays a vital role in advancing orthopedic medicine and patient care, both locally and globally. Embracing a culture of collaboration and innovation, this individual will work closely with internal teams and external partners, including industry leaders and healthcare institutions worldwide, to drive impactful research and improve patient outcomes. The CRC is responsible for coordinating clinical research studies, facilitating patient participation, and preparing, submitting, and tracking documentation of research studies. In addition, the CRC will ensure compliance with local and federal regulations, protocols, and safety monitoring through process audits. The CRC 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. THE CAMPBELL CLINIC FOUNDATION: The Campbell Clinic Foundation is an independent, non-profit 501(c)3 organization with a mission 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. Foundation staff members strive to uphold five core values: capable, collaborative, conscientious, courageous, and curious. We foster a dynamic, forward-thinking team, culture, and workplace. The Campbell Clinic Foundation is affiliated with Campbell Clinic Orthopaedics, and clinical research across sub-specialties takes place in multiple Clinic locations and in partnership with dozens of healthcare partners. Campbell Clinic is an international 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. We honor a century-long legacy of teaching, leading and innovating in orthopaedic medicine and healthcare. Our work improves mobility and quality of life for people in our community and around the world. The position will be based in Germantown, TN.

Requirements

2 years of experience in a clinical and/or healthcare setting required.
1 year research experience required.
Bachelors Degree required.
Able to communicate effectively in the English language.
Proficiency with word processing, spreadsheets, and electronic data capture systems required.
Basic arithmetic skills are required.
Identifies and resolves problems promptly.

Nice To Haves

A current RN license in the state of Tennessee preferred.
Certification as a clinical research coordinator (CCRC, CCRP) is preferred.
Basic Life Support (BLS) certification is preferred.
Knowledge of federal regulations governing research to include but not limited to 21 CFR 50 and 45 CFR 46 is preferred.
Familiarity with medical terminology and medical codes is required.
Knowledge of orthopaedic pathology and surgery preferred.

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 CRCs 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