Principal Quality Auditor – GCP
Precision Medicine Group
Google Cloud Platform
Mid-Level Clinical Site Identification and Start-Up Manager
RTI International
full-time
Posted on:
Origin: • 🇺🇸 United States • North Carolina
Visit company websiteSalary
💰 $64,000 - $79,000 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Lead the site identification and feasibility process for clinical trials, ensuring selection of qualified sites
- Coordinate feasibility assessment ensuring sites meet patient recruitment targets, therapeutic expertise, and operational capabilities
- Build and maintain a network of potential sites and relationships with investigators and site personnel
- Oversee site start-up activities including contract negotiations, regulatory document collection, IRB/IEC submissions, and site initiation visits
- Work closely with regulatory and clinical teams to obtain approvals and prepare sites to begin recruitment
- Ensure timely execution of start-up milestones (Site Contract, Investigator Brochure, IRB/IEC approval)
- Serve as primary point of contact for sites during start-up and collaborate with Clinical Operations, Regulatory, and Legal
- Communicate regularly with sites about timelines, requirements, and expectations
- Track and report site start-up progress to ensure alignment with study timelines
- Identify opportunities for process improvements to streamline site identification and start-up timelines
- Monitor site performance and address challenges including non-compliance or delays
- Ensure adherence to regulatory guidelines (FDA, EMA, ICH-GCP) and company policies
- Maintain accurate and up-to-date records for site start-up activities and documentation
- Provide updates and reports to project team and senior management on site status and delays
- Mentor and provide guidance to junior team members and assist in developing training materials or SOPs
Requirements
- Bachelor’s degree in Life Sciences, Clinical Research, or a related field
- Relevant clinical research certifications (e.g., CCRA, CCRP) preferred but not required
- Minimum of 2 years of experience in clinical trials with a focus on site identification, start-up, or site management within a CRO, pharmaceutical, or biotechnology company
- Experience with regulatory submissions, IRB/IEC submissions, and site initiation processes
- Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms
- Strong knowledge of clinical trial regulations, ICH-GCP guidelines, and the regulatory requirements for site initiation and activation
- Excellent project management skills, with the ability to prioritize and manage multiple tasks and deadlines
- Strong communication and interpersonal skills
- Detail-oriented with the ability to resolve issues and troubleshoot during site start-up
