Job Description

　　Under the general direction of the Study Enrollment Supervisor, the Research Team Recruiter is responsible for the successful recruitment of subject volunteers to participate in Phase I research studies. Provides the Informed Consent Session as delegated by the Principal Investigator. Prepares all required paperwork (source documents, lab requisitions, clinical labels, physical forms, etc.) required to accurately capture all data required by a study protocol in regard to subject inclusion/exclusion criteria.

　　Essential Functions:

　　Reviews protocols to determine study specific inclusion/exclusion information. Evaluates for gaps in information and discusses omissions with Study Enrollment Supervisor and Clinical Research Manager (CRM) to develop clear criteria.Sets up screenings for participants. Sets up the number and times of screenings and physicals to meet team and staffing needs. Keeps the Senior Research Technician staff apprised of screening times to ensure adequate help with procedures. Arrives 30 minutes prior to scheduled screening with completed screening paperwork for the required number of screening participants.Conducts the Informed Consent session by reading aloud 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.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.Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. These documents include Medical History, Physical Exams, Study Dates and Information, Study Demographics, Study Admission Records, Screening and Eligibility Review Forms, Screening Log, Sign-in Sheets, Volunteer Tracking Form and any other form required. Reviews computerized phone-screening tool for accuracy.

　　Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification / 0-1 Year experience

　　Job Complexity:

　　Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

　　Job Knowledge:

　　Applies acquired job skills and company policies and procedures to complete assigned tasks.

　　Supervision Received:

　　Normally follows established procedures on routine work, requires instructions only on new assignments.