Regulatory & Start-Up Specialist 1

About This Role

We are representing a confidential clinical research organization seeking a Regulatory & Start-Up Specialist to join their remote team. In this role, you'll serve as the single point of contact for investigative sites and project teams, managing site activation activities and regulatory documentation in accordance with applicable regulations and standard operating procedures.

Responsibilities

• Serve as the primary contact for investigative sites, project management teams, and internal departments across assigned clinical studies
• Perform site activation and start-up activities, ensuring compliance with regulatory requirements and standard operating procedures
• Prepare, review, and distribute site regulatory documents, ensuring completeness and accuracy
• Maintain internal systems, databases, and tracking tools with project-specific information
• Review site performance metrics and provide feedback to management
• Establish project timelines and implement contingency plans as needed
• Track and follow up on regulatory approvals, ethics submissions, informed consent forms, and investigator pack release documents
• Conduct quality control reviews of site-provided documentation
• Provide country-level expertise during project planning phases
• Communicate document completion status to internal project team members

What We're Looking For

• Minimum 1 year of clinical research experience, or an equivalent combination of education, training, and experience
• Strong understanding of regulatory requirements and standard operating procedures in clinical research
• Excellent attention to detail for document review and quality control
• Ability to manage multiple projects and timelines simultaneously
• Strong communication skills for coordinating with sites and internal teams
• Proficiency with databases and tracking systems
• Remote work capability with reliable home office setup

How We Work With You

Candidates apply directly through the Get A Job.ai platform. Our talent team conducts an initial screening to understand your background and career goals. We then submit qualified candidates to our client for consideration. Please do not contact the client organization directly, as all applications must come through our recruiting process to be considered.

Pay

Our client has not disclosed compensation details at this time. Pay will be discussed during the interview process based on your qualifications and experience.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from all qualified candidates regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.