Coordinator Clinical Research

Position Summary

Responsible for facilitating research studies; providing knowledgeable information regarding each research protocol to the medical and nursing staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and maintain a system for effective data flow.

Essential Functions and Responsibilities

• Evaluates eligibility of candidates for clinical research studies by reviewing protocol defined eligibility requirements and/or collecting pertinent data on potential candidates, verifying appropriateness of patients for entry to clinical trials, and assisting the other staff in determining eligibility of potential patients.
• Affords assistance with the informed consent process and ensures that the research team and the patient have adequate information to achieve the informed consent process.
• Registers and randomizes eligible patients.
• SUBMIT ACCURATELY COMPLETED DATA COLLECTION FORMS TO THE SPONSOR OR CRO IN A TIMELY MANNER AS DICTATED BY THE STUDY PROTOCOL.
• COORDINATES TESTS AND PROCEDURES AS SPECIFIED IN THE STUDY PROTOCOL THROUGH ACCURATE COMMUNICATION WITH THE SITE / PRINCIPAL INVESTIGATOR, PHYSICIANS, PATIENTS, NURSES, AND OFFICE/HOSPITAL STAFF.
• Maintains contact with regulatory specialist to ensure data submitted to the IRB of record is accurate and timely.
• Upon request, SUBMITS REGULATORY DOCUMENTS TO REGULATORY SPECIALIST TO INCLUDE IN THE IRB SUBMISSION OR SUBMISSION TO SPONSOR OR CRO.
• AFFORDS ASSISTANCE TO THE INVESTIGATORS AND CLINICIANS IN IDENTIFYING AND ENROLLING ELIGIBLE PATIENTS INTO CLINICAL TRIALS/STUDIES AND ASSURES COMPLIANCE TO PROTOCOL REQUIREMENTS.
• EDUCATES PATIENTS AND THEIR FAMILIES REGARDING RESEARCH PROTOCOLS AND KEEPS THEM INFORMED OF PROCEDURES AND CHANGES IN THE STUDIES IN WHICH THEY ARE PARTICIPATING.

Qualifications

• Required: High School Diploma or equivalent Two years’ experience in clinical research or five-years in a health care role (ex. paramedic, emergency medical technician, radiology technician)
• PREFERRED: Degree in biology, psychology, or other clinical research -related area or equivalent education and experience Three or more years of experience in clinical research Clinical research certification through SOCRA or ACRP

Additional Information

• Schedule: Full-time
• Requisition ID: 26002728
• Daily Work Times: 8am - 4:30pm
• HOURS PER PAY PERIOD: 80
• On Call: No
• Weekends: No