Research Quality and Regulatory Specialist

JOB SUMMARY: The Research Quality and Regulatory Specialist will support the department by ensuring adherence to regulatory standards, procedural compliance, and the maintenance of quality systems within the Research department.

in accordance with local and Federal regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans.

Job Specific Duties and Responsibilities: Seeks current information and maintains current knowledge base to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, Revised Common Rule, 46 CFR 46, standards for accreditation, etc.)Assists with the development of new SOPs and reviews and provides revisions of current research SOPs as needed.Conducts regular audits to identify potential deviations from study protocol or regulatory documents in compliance with local, state, and federal regulations.Prepares quality management reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.Assists with compliance and quality assurance issues and supports external regulatory site visits, providing regulatory input to minimize potential for non-compliance findings.Evaluates study protocols, informed consent forms, and other essential documents to ensure compliance with regulatory requirements and site standards.Reviews the collection and documentation of data from clinical trial patient visits.Performs regulatory management of clinical trials, which may cover submission in the study startup phase through study closeout.Prepare, track, and maintain all correspondence and documentation required by the IRB, FDA, and other institutional oversight committees as appropriate for the clinical trials to which they have been assigned.Prepares timely submissions of regulatory documents to Sponsor and Central IRB as appropriate.Maintain clinical trial regulatory compliance with GCP, institutional, and federal regulations.Collaborates with clinical trial coordinators and leadership to maintain up to date clinical trial documentation and retraining.Maintains Investigator Site File (ISF) within eRegulatory system and legacy binders.Maintain timely continuing review (CR) submissions.Prepare regulatory materials for monitoring visits; serve as primary point of contact for scheduling monitor visits and set calendar holds for finalized visit dates.

Includes access to eRegulatory training and study visit log requests for Clinical Research Assistants (CRAs).Exercises appropriate judgement in evaluating audit findings while reporting regular updates of non-compliance of all severities to supervisor.Documents and develops corrective or preventative action plans in a timely manner.Provides guidance and training to research staff to ensure compliance with rules and regulations associated with the departments clinical research studies.Monitor IRB communications within the electronic portals.Assists in submission o...