Palmetto Health Medical Group Research Coord I in Columbia, South Carolina
All employees are expected to be knowledgeable and compliant with Palmetto Health USC Medical Group's values of compassion, dignity, excellence, integrity and teamwork.
Job Summary: The Research Coordinator plans, coordinates, evaluates, and manages subject recruitment, enrollment, and follow-up for observational and/or registry clinical research studies. This job ensures compliance with study specific protocol guidelines and all applicable federal, local, and institutional regulations, guidelines, and best research practices. On each study, the Research Coordinator works in collaboration with a Research Nurse, who oversees the clinical aspects of the research.
Education: Associate's degree in health science related field preferred or equivalent in education plus experience
Experience: At least three years of full-time employment in a professional position; two years of research experience preferred.
Number and Type of Employees Supervised: None
Licensure, Registry or Certification Required: Valid South Carolina driver's license, an acceptable three-year motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and a certificate of auto insurance; Research certification, Certified Clinical Research Professional (SoCRA) or Certified Clinical Research Coordinator (ACRP) preferred.
Special Training: Must complete human subject protection and government regulations training; must be proficient with Microsoft Office (Word and Excel); must possess quality written and oral communication skills; must be able to think creatively, analytically, independently, and objectively; must be able to handle stressful situations. Driving is required for this position using the employee's personally owned vehicle. Employee will be expected to adhere to the Palmetto Health Driver Safety Policy and specific department driving policies. Employee must pass driver training.
• Recruits potential subjects for participation in clinical research trials.
• Screens potential subjects for eligibility in research trials, based on the study protocol's inclusion and exclusion criteria, and determines subjects' suitability for participation.
• Participates in and documents the initial and the continuing informed consent process for subjects and/or subjects' legally authorized representative.
• Ensures subject and clinical research team (consisting of physicians, research nurses, non-clinical research staff, management, and ancillary staff) compliance with protocol requirements.
• Explains the non-clinical aspects of the study consent and other protocol information to subject and staff as necessary.
• Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
• Communicates with the Institutional Review Board (IRB), regulatory agencies, sponsors, the clinical research team, and/or other organizations as may be required for successful completion of the research study and provides ongoing updates and progress reports to the clinical research team.
• Assists in the development of a coverage analysis grid and the identification of impacted services during study start-up.
• Enters subject and study visit information into the system of record in a timely fashion.
• Performs other assignments as directed.