PS Regulatory Coordinator

Job Summary

Regulatory coordination is a specialized function within clinical trials operations responsible for all regulatory processes across multiple studies in compliance with local and federal regulations, Standard Operating Procedures (SOP's), and study-specific protocols.

Responsibilities

• Supports all aspects of regulatory compliance as it pertains to the essential components of a clinical trial including submissions to IRB and internal ancillary committees.
• Prepares regulatory documents, including informed consent form, and other required regulatory documentation;
• 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).
• SUBMIT STUDY RENEWAL APPLICATIONS AND STUDY PROGRESS REPORTS TO THE IRB;
• CORPORATES 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;
• MANTAINS CURRENT KNOWLEDGE OF FEDERAL AND INSTITUTIONAL GUIDELINES AND REQUIREMENTS GOVERNING RESEARCH;
• MANTAINS REGULATORY DOCUMENT DATABASE;
• GENERATES AD HOC REPORTS AS REQUESTED;
• CORPORATES WITH STUDY SPONSOR, INVESTIGATOR AND IRB TO COMPLETE STUDY CLOSURE ACTIVITIES;
• COORDINATES AND PERFORMS RESPONSIBILITIES RELATED TO RESEARCH PARTICIPANTS INCLUDING DEVELOPING INFORMED CONSENT OVERSEES APPROPRIATE APPROVAL OF ALL PATIENT RELATED MATERIALS BY APPROPRIATE REGULATORY REVIEW COMMITTEES;
• PREPARES FOR AND PARTICIPATES IN AUDITS MADE BY SPONSORS OR FEDERAL AGENCIES DURING COURSE AND AT THE CLOSE OF THE STUDY;
• PREPARES, SUBMITS AND MAINTAINS IRB AND/OR OTHER REGULATORY DOCUMENTS AND RESEARCH CORRESPONDENCE FOR ALL INVESTIGATOR-INITIATED, NCI AND INDUSTRY SPONSORED CLINICAL STUDIES.

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.