Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
Job Overview:
Under the general direction of the Clin Ops Supervisor, the Research Team Recruiter is responsible for the successful completion of the screening phase of all early and late phase trials within the Clinical Research Unit. This entails, but is not limited to, conducting a screening session to provide the Informed Consent session as delegated by the Principal Investigator. Prepares all requires paperwork (source documents, lab requisitions, supplies, eligibility packet and any other screening related items required to capture all data within the protocol. Thoroughly reviews inclusion and exclusion requirements to ensure all study participants meet requirements of the protocol.
Essential Functions:
- Reviews protocols to determine study specific inclusion/exclusion information. Evaluates for gaps in information and discusses omissions with Supervisor and Clinical Research Manager to develop clear criteria.
- Requests screenings appointments for participants. Considers the number of appointments and times of screenings and physicals to meet study needs. Arrives 30 minutes prior to scheduled screening with complete screening paperwork for the required number of screening participants.
- Conducts the Informed Consent session by reading aloud the designated primary focus points of the most recently approved version of the Informed Consent to volunteers while the volunteers follow along with their own copies.
- Ensures each subject screened has been properly consented, has a signed informed consent, and all questions answered prior to any procedures being performed and continuing in the screening process with a good understanding of all methods of consent capture.
- Ensures all study participants’ paperwork is complete and adequately reflects their participation in the study screening process. Ensures all subjects’ and screening failure paperwork is kept with the study to meet FDA requirements.
- Ensures physician reviews all clinical labs, ECGs and other tests as required and keeps Clinical Research Manager appraised of recruitment information.
- Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. Fully utilizes all internally required forms, checklists and tracking sheet to ensure excellent management of participants throughout screening process.
