Charlotte, NC, United States
Job ID: 9512
Job Family: Research Services
Status: Full Time
Shift Details: Regular
Department Name: 55541005030161-Minimally Invasive Surgery
Location: AH CMC Main - 1000 Blythe Blvd
Assesses, plans, coordinates, and evaluates the operational functions of clinical research. Manages the various studies and ensures compliance with regulatory agencies.
- Coordinates and facilitates day to day operations associated with research projects; analysis, financials, outcomes.
- Manages subjects via recruitment, informed consent, protocol assessments, and data collection.
- Initiates and maintains relations for study protocols. Interviews and trains new research staff.
- Reviews, maintains, and archives study administrative and data management files. Manages sponsored projects.
- Assists in monitoring compliance and communication.
- Plans for future trends in clinical research.
Additional Essential Functions
- Oversees and coordinates systems, contracting, grants, funding, pre- to post-award transition, non-financial post-award management associated with sponsored programs.
- Acts as a system-wide alternate Authorized Organization Representative and as a Signing Official.
- Determines protocol-related needs to conduct the trial and orders supplies and equipment.
- Recruits and screens potential patients and obtains informed consent.
- Assists in providing patient education and benefits and risks of participating in a clinical drug trial.
- Designs organizational tools and forms to facilitate accurate data collection and recordkeeping.
- Conducts in-service programs, summarizes study schedule to assist in understanding and implementing a protocol.
- Manages research funds.
- Schedules patient visits and laboratory and diagnostic test procedures.
- Coordinates drug shipments, storage, and accountability with pharmacy.
- Coordinates with Investigational Pharmacy for subjects to receive required drugs.
- Reviews trends, problems encountered, patient adverse events, and patient progress.
Additional Training and Certifications
• Certified Research Administrator certification preferred
• Strong experience with administration of sponsored programs (grants, cooperative agreements and contracts) preferred
Works in both inpatient and outpatient clinical care areas. May be required to travel to local area hospitals and physician offices. Works in office environment. Requires walking, sitting, operation of keyboard and computer. Responsible to work in a safe manner.
Education, Experience and Certifications
Bachelor's Degree required; Master's Degree in Business or Health Care Administration preferred. Previous research experience preferred. Knowledge of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines, basic scientific methods, biological principles, medical terminology, and regulatory requirements of the FDA and IRB preferred.