Research Study Coordinator
Reports to: Medical Director
Status: Full-time, Hourly, Non-exempt
Essential Duties & Responsibilities
Includes the following. Other duties may be assigned.
Obtains detailed knowledge of all components of assigned study protocols through independent analysis and review of study, prior to study initiation.
Reviews with supervisor prior to study initiation any components of the study that require additional information or clarification.
Reviews synopses with potential participating providers to gain their commitment to studies.
Identifies potential study participants.
Validates potential participant data against pre-established study inclusion and exclusion criteria.
Provides study sponsor information during and between audit visits.
Completes, maintains and processes case report forms in compliance with good clinical practices.
Works with study monitors during monitoring visits to provide data clarification/correction when needed.
Ensures that laboratory specimens collected, processed and shipped according to study requirements.
Schedules all visits and procedures and provides instructions and dates to participants.
Makes reminder phone calls to all participants with appointments scheduled for the following day.
Coordinates with per diem physicians as needed for participant examinations.
Acts as a liaison between study participants and their physicians concerning any problems, adverse reactions, etc., related to the study medication.
Notifies participants, physicians, monitors and institutional review boards (if required) of any serious or unwanted adverse reactions to study medication.
Immediately reports to the principal investigator and institutional review board any known deviations from established policies or procedures.
Follows directions provided by the principal investigator and the Nurse Manager and acts accordingly.
Obtains clarification from the principal investigator of established policy prior to taking action which might deviate from standards.
Participation in Meetings/Committees
Attends meetings as assigned.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelors degree (B.A.) from four-year college or university; or one to two years related experience and/or training or equivalent combination of education and experience.
Computer/Software Skills & Abilities
To perform this job successfully, an individual should have knowledge of Word Processing software.