Why RTI
RTI International (RTI) is both a global research institute and a leading international development organization based out of North Carolina. At RTI, you will find work you believe in, tackling some of the most complex global challenges of our time. Our mission is to impact the wellbeing of 1 billion people by 2030 through science-based solutions in climate, education, health, and equity. Our staff promote meaningful change around the world helping people live healthier, more productive, and more independent lives.
If you are looking for an opportunity to make a real difference, RTI is the place for you. Join us in our commitment to teamwork, belonging, and the passion to change the world.
About the Hiring Group
We are seeking a Mid-Level Clinical Site Identification and Start-Up Manager to oversee and manage the end-to-end process of site identification, selection, and start-up activities for clinical trials. This mid-level position will play a pivotal role in ensuring the timely initiation of clinical trial sites and will work closely with cross-functional teams, including Clinical Operations, Regulatory, and Project Management, to ensure high-quality and compliant site initiation processes. The ideal candidate will have a strong background in clinical trials, site management, and regulatory compliance, with a focus on driving efficiency and ensuring successful site activation.
Please note, this position manages the study, but does not have administrative management responsibilities for any staff.
What You'll Do
Site Identification & Feasibility :
- Lead the site identification and feasibility process for clinical trials, ensuring the selection of qualified sites that align with trial requirements and sponsor expectations.
- Coordinate the feasibility assessment process, ensuring the sites meet patient recruitment targets, therapeutic expertise, and operational capabilities.
- Build and maintain a network of potential sites, ensuring strong relationships with investigators and site personnel.
Site Start-Up Activities :
Oversee the site start-up activities, including contract negotiations, site feasibility assessments, regulatory document collection, IRB / IEC submissions, and site initiation visits.Work closely with the regulatory and clinical teams to ensure that all regulatory and ethical approvals are obtained and the site is prepared to begin recruitment.Ensure timely execution of essential start-up milestones (e.g., Site Contract, Investigator Brochure, IRB / IEC approval, etc.).Site Identification & Feasibility :
Serve as the primary point of contact for sites during the start-up phase and collaborate with internal stakeholders such as Clinical Operations, Regulatory, and Legal departments to ensure smooth site activation.Communicate regularly with sites to ensure understanding of timelines, requirements, and expectations during the start-up process.Track and report on site start-up progress to ensure alignment with overall study timelines and project goalsProcess Improvement & Compliance :
Continuously identify opportunities for process improvements to streamline site identification and start-up timelines while ensuring regulatory compliance and quality standards.Monitor site-specific performance, addressing any challenges to ensure on-time activation and resolution of issues, including site non-compliance or delays.Ensure adherence to regulatory guidelines (FDA, EMA, ICH-GCP) and company policies during the start-up process.Documentation & Reporting :
Maintain accurate and up-to-date records for the site start-up activities and documentation (e.g. / essential documents, regulatory approvals, contracts, etc.).Provide timely updates and reports to the project team and senior management on site status and any potential delays or challenges.Ensure completion and submission of necessary documentation for regulatory and sponsor review.Training & Mentorship :
Mentor and provide guidance to junior team members or colleagues involved in site identification and start-up activities.Assist in developing training materials or standard operating procedures (SOPs) to enhance site identification and start-up processes.What You'll Need
Bachelor’s degree in Life Sciences, Clinical Research, or a related field.Relevant clinical research certifications (e.g., CCRA, CCRP) are 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 is essential.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, with the ability to work effectively with both internal and external stakeholders.Detail-oriented with the ability to resolve issues and troubleshoot challenges during site start-up.LI-KV1
