Regulatory Start-Up Specialist

Position: Regulatory Start-Up Specialist

Location: Houston, TX

Job : 1146

# of Openings: 1

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.

• 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.

• Bachelor’s degree or equivalent in a relevant field (e.g., life sciences, health care, regulatory affairs) Required

• 2+ years of experience in clinical trial start-up and regulatory affairs
• Experience or knowledge with Florence documentation system, preferred

• ACRP-CP or the ability to obtain one within 12 months.

• 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