Clinical Research Regulatory Specialist

About Us At Rovia Clinical Research, we’re on a mission to bring innovative treatments to patients, improving the health and lives of our local patient communities. We believe in building a workplace where people feel supported, valued, and excited to grow their careers. Whether you’re just starting out or looking for a new path, you’ll be part of a team that truly works together and makes an impact.Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability. 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. Originally posted on Himalayas