Job Summary

Manages protocols to ensure the safety of patients and quality of clinical trial data. Prepares and submits Institutional Review Board (IRB) paperwork and maintains all related regulatory document submissions. Communicates and coordinates study activities with the Primary Investigator and any Sub-Investigators of clinical studies.

Essential Functions

• 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.
• Draws blood or collect other samples as needed and eligible.

Physical Requirements
Works in clinical care areas and office environments. May be required to travel. Requires close, personal contact with patients, handling of blood and body fluids, walking, sitting, standing, lifting, handling of charts, supplies and equipment, and operation of a keyboard and computer. Responsibility to work in a safe manner.

Education, Experience and Certifications

Bachelor's Degree and research experience required. Master's Degree preferred. Phlebotomy certification or venipuncture skills preferred. BLS required per policy guidelines. Certification in clinical research (SoCRA, ACRP) preferred.