PS Regulatory Coordinator

Job Summary

Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.

Responsibilities

Supports all aspects of regulatory compliance. Prepares regulatory documents, including consent forms for submission to research review committees. Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Tracks study approvals and expirations to ensure uninterrupted project approval. Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB). Submits study renewal applications and study progress reports to the IRB. Coordinates with study sponsor, investigator and IRB to complete study closure activities. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission. Recommends and implements regulatory process improvements. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Maintains regulatory database. Generates ad hoc reports as requested.

Work Environment and Level of Frequency typically 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 research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

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.

Preferences

(No specific preferences listed)

Special Instructions

(No specific instructions listed)