Regulatory Start-Up Specialist

Regulatory Start-Up Specialist The Regulatory Start-Up Specialist serves as the main point of contact for project-specific study start-up activities within the regulatory department and provides regular updates to relevant stakeholders on the completion status of the initial regulatory packet. DUTIES & RESPONSIBILITIES Manage and coordinate Regulatory Department activities related to clinical trial start-up at clinical sites, including IRB/IEC and IBC submissions, informed consent review, essential document collection, and preparation for site initiation and activation.

Collaborate closely with site operations and cross-functional stakeholders to ensure efficient start-up processes for assigned projects in compliance with ICH-GCP guidelines, relevant Standard Operating Procedures (SOPs), and sponsor-specific requirements. Serve as the primary point of contact for all regulatory specific study start-up activities within the regulatory department.

Develop and maintain site-specific IRB/IBC submission and approval timelines based on site-specific information and sponsor expectations, ensuring adherence to deadlines, and providing clear rationale for any delays and contingency plans to mitigate their impact. Proactively anticipate and identify regulatory start-up issues during the start-up process, and independently resolve minor to moderate issues while escalating complex issues to study team members in consultation with HOD.

Draft, review, and distribute essential documents and templates for mass distribution to sites, including initial welcome packets and arrangements for receipt of essential documents. Obtain necessary signatures on regulatory essential documents in a timely manner. Regularly provide updates to the direct line manager, Project Management team, and other relevant stakeholders on the completion status of the initial regulatory packet Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation.

Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information and identify any issues that may delay or hinder the start-up process. KNOWLEDGE & EXPERIENCE Education: Bachelor’s degree or equivalent in a relevant field (e.g., life sciences, health care, regulatory affairs) Required Experience: 2+ years of experience in clinical trial start-up and regulatory affairs Experience or knowledge with Florence documentation system, preferred Credentials: ACRP-CP or the ability to obtain one within 12 months.

Knowledge and Skills: Working knowledge of ICH-GCP guidelines and regulations governing clinical trials Strong project management skills and attention to detail Excellent communication and interpersonal skills Ability to work independently and as part of a team Proficiency with Microsoft Office applications and document management systems Strong organizational and documentation skills