PS Study Coordinator

Job Summary

Captures technical and administrative details for clinical or research studies. Assists the Principal Investigator in ensuring study integrity and objectives.

Responsibilities

• Affirms protocol clarity and subject safety, reviews inclusion/exclusion criteria, addresses concerns.
• Attends and participates in Investigator and staff meetings, advises on study assignments and timelines.
• Assists with informed consent, medical history, demographics documentation, and tracking adverse events.
• Determines visit lengths, coordinates facility and equipment availability, reports and tracks adverse events.
• Reports and documents protocol deviations, reconciles test article accountability, prepares summary reports.
• Completes, audits, and corrects CRFs, relays to sponsors, negotiates contract budget and payment terms.
• Maintains documents per FDA guidelines, ensures proper specimen collection, processing, and shipment.
• Performs functions as a Clinical Research Assistant as needed.

Problem Solving

Coordinates daily operations, ensures orderly and safe research project flow, maintains adequate resources for PI objectives.

Physical Requirements

Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion, walking. Seldom: Bending, reaching overhead.

Minimum Qualifications

• Bachelor’s degree in a related field or equivalent, one year of education can substitute for two years of related work experience.
• IRB CITI course in the Protection of Human Research subjects certificate within six months of hire.
• Demonstrated human relations and effective communication skills.
• Some departments may require IATA DGR training within six months.

Patient-Sensitive Position

Must fulfill all associated vaccination requirements or be approved for an exemption prior to first day of work.

Preferences

• Type: Benefited Staff
• Special Instructions: Summary Additional Information