The Regulatory Affairs Coordinator will assist the clinical study teams in the start-up of clinical studies including, but not limited to, regulatory document processing, database management, maintenance of central files, data tracking systems and ad hoc reports.
Responsibilities of the Job & Essential Job Outcomes * Prepare and maintain research project submissions per institutional and regulatory standards. * Assure all site documents including SOPs and administrative files are maintained in audit-ready condition. * Coordinates regulatory activities for multiple clinical research projects. * Prepare regulatory binders for study team use and conduct periodic document quality check. * Oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support. * Follow standard operating procedures, good clinical practice and sponsor instructions / specifications. * Assist in obtaining initial documents for clinical trial procurement and site selection. * Compile research protocol documents and all materials required for regulatory submissions in compliance with institutional and federal policies. * Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol. * Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions. * Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov. * Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership. * Maintains current and accurate documentation in the regulatory binders (paper or electronic) as required by regulations and sponsors. * Participates in required teleconferences, on site meetings and off site investigator meetings, as required. * Other duties as assigned.
* Two years of experience in the field of regulatory documentation management or clinical research. * Knowledge of clinical trial federal, state and local regulations required. * Must have strong MSOffice computer skills, and ability to conduct Internet searches. * Strong project management, analytical, organizational, and problem solving skills. * Superior interpersonal and communication skills. * Demonstrated ability to work on deadlines, set priorities and coordinate multiple projects without compromising quality.
Education * Bachelor of Science or Arts or Sciences degree required. * RAPS, ACRP, or SoCRA certification preferred. * Current CITI training certification preferred.