Overview
Job Summary
Assesses, plans, coordinates, and evaluates the operational functions of clinical research. Manages the various studies and ensures compliance with regulatory agencies.
Essential Functions
- 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.
Physical Requirements
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.
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