Clinical Research Assistant

CLINICAL RESEARCH ASSISTANT

JOB SUMMARY:

• Assists coordination and implementation of research studies while assisting the Principal Investigator and Lead Coordinator in determining and accomplishing study objectives.
• Assures compliance with guidelines set by governing agencies.
• Attains adequate cohesiveness between clinical research, physician, staff & patients.
• Requires exceptional attention to detail, organizational skills and effective human relations, and effective communication skills are also required.
• Independent professional with ability to see the big picture and communicate effectively.
• Knowledge of Good Clinical Practices (GCP), FDA, HIPAA, and IRB regulations; an understanding of research procedure; and the ability to function independently.
• Demonstrates the ability to perform the essential functions of the job and care appropriate to the population served.

FUNCTIONS:

• Compliance to protocol; manages quality control, completion, and submission of study related documentation; prepares reports for organizations and agencies.
• Assists Lead Coordinator with enrollment goals and initiates strategies to promote enrollment and participate compliance.
• Coordinates and performs responsibilities related to research participants including determining subject population availability, understanding of informed consents, and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consents, answering subject questions, overseeing study visits and acting as a liaison between participants and study-related parties as directed by PI and Lead Coordinator.
• Responsible for recruiting candidates for clinical drug trials for health-related issues and to make sure the candidate has a full understanding of the trial they are about to undertake.
• Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and the close of the study.
• Contributes to developing educational materials and educated the community and other research professionals regarding studies and related research issues.
• Coordinates with referring physicians to provide pertinent information regarding available research projects and to maintain a strong referral basis.
• Maintains patient databases, investigational logs, regulatory binders and drug accountability (dispensing, storage & security).
• Assists the Principle Investigator and Lead Coordinator with effective commutation & organizational skills.
• Education of related information to non-research clinical staff,
• Maintains a professional atmosphere with staff, as well as, study subjects.
• Records daily temperature monitoring for all IP.
• Responsible for all IP security & accountability logs.
• Maintains a good working relationship with sponsors and monitors.
• Keeps PI information of all study related information.
• Maintains clean, stocked research exam room.

Job Type: Full-time with great benefits

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: One location