Regulatory and Site Start Up Specialist

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities include initial and subsequent clinical trial submissions to Competent Authorities and IRB/Ethics Committees, informed consent form review and adaptation, essential document collection and quality review, and supporting sites on IRB/EC submissions.

The RSS may act as a Subject Matter Expert for questions by other in-country members (CRAs, CSSs, or others) supporting site start-up activities and may contribute to the development or revision of country-specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• Ensuring delivery of site activation readiness within the assigned country/sites in terms of timeliness and quality, foreseeing and mitigating risks.
• Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committees (EC), and other applicable local bodies according to local requirements and within required timelines.
• Interacting with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead, Regulatory Lead, and Project Manager/Project Team.
• Maintaining project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities and keeping Regulatory Leadership updated.
• Preparing and supporting the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partnering with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Preparing, reviewing, and managing the collection of essential documents required for site activation/IMP release.
• Customizing country/site-specific Patient Information Sheets and Informed Consent Forms.
• Responsible for facilitating the translation and coordination of translations for documents required for submission.
• Maintaining communication with other key functions participating in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management.
• Acting as a Subject Matter Expert (SME) for collection and maintenance of site-level critical path data points, including CA, local IRB/Ethics Committee timelines, site contracts, budget negotiation requirements, and other reviews to secure on-time site activation.
• Participating in the negotiation of study budgets and execution of investigator contracts under the direction of the Site Contract Management department.
• Supporting the feasibility group in site outreach to assess potential interest of investigators in a potential study.
• Keeping an updated knowledge of local clinical trial laws and regulations and distributing this knowledge within Precision for Medicine (PfM) to ensure compliance with international and local/national regulations.
• Maintaining audit/inspection readiness at all times and filing documents as per TMF plan and/or study-specific plans in the relevant TMF.
• Supporting the clinical team performing Pre-Study Site Visits.
• Supporting process improvement initiatives, training, and mentoring.
• Performing other duties as assigned by management.