Job Description

Responsibilities
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor. Completes, audits, corrects CRFs, relays CRFs to sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines.

May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection, processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary.
Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Some departments may require IATA DGR training within six months.