Clinical Research Regulatory Specialist

Position Summary: The Clinical Research Regulatory Specialist will work as an integral member of the research staff by maintaining day-to-day regulatory tasks within the site network, assisting with the execution of clinical studies in accordance with the protocol, contract scope of work, ICH/GCP, sponsor, CRO, Rovia SOPs, and any relevant local guidelines and regulations. Key Responsibilities: Performs startup activities including IRB submissions, regulatory documentation, vendor and training access, etc. Assists with the management of Rovia’s eRegulatory platform Florence, including creating study binders, filing startup and maintenance documents, performing quality checks, monitoring investigator and site credentials, etc. Completes regulatory documentation such as Financial Disclosure Forms (FDFs), Protocol Signature Pages (PSPs), FDA 1572s, and Investigative Brochure Signature Pages. Routes regulatory documents to research staff and investigators to obtain signatures and follow up as necessary. Works collaboratively with investigators and research staff to complete outstanding documents. Returns regulatory documents and credentials to the sponsor/CRO in a timely manner. Creates delegation of authority logs and adjusts as needed throughout the study duration. Creates training logs. Performs reviews of the Investigator Site Files (ISFs) for completion and accuracy. Gathers documents requested during Site Selection Visits (SSVs) including copies of research staff/investigators curriculum vitae (CVs), medical licenses (MLs), Good Clinical Practice (GCP) training certificates, Rovia SOPs, site equipment calibration logs, etc. Creates investigator curriculum vitaes (CVs) and updates on a biannual basis or as requested. Obtains and maintains valid medical licenses for all investigators. Participates in the development of company SOPs and Guidance Documents (GDs) as needed. Creates and submits continuing reviews, protocol deviations, and any other ongoing IRB submissions. May perform other job-related duties as requested or required. Skills/Abilities: Sound knowledge of medical terminology. Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices. Excellent interpersonal skills to interact effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors, and sponsors. Meticulous attention to detail. Ability to maintain confidentiality. Strong written communication skills. Strong organizational skills. Proficient in the use of Microsoft Office, Microsoft Excel, and Adobe Acrobat. Ability to meet multiple and changing deadlines Ability to consult numerous sources for information to prepare documents. Fluent in spoken and written English. Education/Experience: High school diploma required, bachelor’s degree preferred. 1-2 years of clinical research experience with an emphasis in regulatory and QA. License/certification status with CEUs, as applicable. Current GCP certification.