Description
Why RTIRTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world’s most challenging problems.We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you. About the Hiring GroupRTI International, an independent nonprofit research institute dedicated to improving the human condition, is seeking a Lead Site Manager to support a large, NIH-funded Long COVID clinical trials program. This role will partner closely with the Site Managing Director to oversee site management activities and support a team of Site Managers across a national network of clinical trial sites. The successful candidate will provide operational leadership, oversight, and hands-on support to ensure high-quality, compliant, and timely execution of site-level activities across multiple protocols. What You'll DoEssential Duties: Program & Site Operations LeadershipOversee and support site management functions in collaboration with the Site Managing Director, ensuring consistent execution of site management activities across the portfolio of trials.Provide day-to-day operational leadership and support for site management team staff, including workload planning/assignments, issue resolution, and implementation of standardized processes.Support site identification, feasibility/qualification, start-up, activation, maintenance, and close-out activities, with respect to coordination of associated timelines and deliverables.Serve as an escalation point for site-related operational challenges and partner accordingly with cross-functional teams to implement effective solutions.Site Contracting & Regulatory CoordinationSupport and coordinate site contracting activities in collaboration with the contracts and finance team, including resolving site-level issues that may impact start up timelines.Oversee and support site management team staff in the collection, review, and maintenance of essential regulatory documents (e.g., CVs, medical licenses, training documentation, FDA Forms 1572, financial disclosures) in accordance with protocol, GCP, and NIH requirements.Partner with regulatory affairs and central IRB teams to help oversee site IRB submissions, approvals, continuing reviews, and amendments.Ensure regulatory readiness of sites prior to activation and throughout trial conduct.Vendor & CRO OversightServe as a primary operational interface with key external vendors supporting site management activities, including CROs or vendors responsible for site monitoring and oversight, patient recruitment, and statistical analysis and data management (e.g., EDC vendor, etc.).Coordinate closely with monitoring vendors to align site management and monitoring activities, address findings, and support timely issue resolution.Review and track vendor deliverables related to site performance, monitoring outcomes, and compliance.Escalate site- or vendor-related risks and collaborate with internal teams and vendors to implement corrective and preventive actions.Support vendor onboarding, communication workflows, and ongoing collaboration to ensure efficient integration with site operations and relevant cross-functional teams.Client & Stakeholder SupportSupport interactions with NIH program staff and external stakeholders related to site operations, contracting progress, regulatory compliance, and vendor-supported activities.Contribute to preparation for NIH meetings, reviews, reporting, and audits.Ensure clear, consistent communication between program leadership, vendors, and participating sites.Quality, Performance & Risk ManagementMonitor site performance metrics, including enrollment, retention, protocol adherence, data quality, and regulatory compliance.Review monitoring trends and findings in partnership with the site monitoring CRO to readily identify systemic issues.Support development and implementation of corrective and preventive actions to address both site- and vendor-related risks.Promote continuous process improvement and standardization across the site network.Cross-Functional Team CollaborationWork closely with clinical operations (protocol management), regulatory, central IRB, statistics and data management, technology infrastructure and contracts and finance teams to ensure integrated site support.Contribute to development and refinement of SOPs, templates, tools, and training materials related to site management, regulatory compliance, and vendor coordination.Support onboarding, mentoring, and professional development of site management staff.Programmatic SupportAssist in planning for onboarding of new sites and support for additional protocols as the program evolves.Provide operational input into resource planning, timelines, and budgeting related to site management, regulatory activities, and other functions supported by external vendors.Ensure continuity of leadership and coverage in partnership with the Site Managing Director. What You'll NeedRequiredBachelor's Degree and 12 years of experience, Master's degree and 10 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience. Experience with NIH-funded or government-sponsored trials.Strong knowledge of GCP and regulatory requirements.Prior experience as a Lead Site Manager, Lead CRA, or equivalent position titleAbility to work in a matrixed environment.To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc).PreferredFamiliarity with Long COVID or chronic disease research.Experience with site performance metrics.Relevant clinical research certifications (e.g., CCRA, CCRP) are preferred but not required.Proven experience managing site start-up, enrollment, and follow up for Phase I-IV clinical trials across multiple therapeutic areas.Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating complex regulatory and ethical processes for clinical trial start-up.Prior experience managing or leading a team and providing mentorship and training to junior colleagues is highly desired.#LI-KV1 EEO & Pay Equity StatementsFor San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here. RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance. Equal Pay Act Minimum/Range$139,000 - $170,000Responsibilities
Qualification
RequiredBachelor's Degree and 12 years of experience, Master's degree and 10 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience. Experience with NIH-funded or government-sponsored trials.Strong knowledge of GCP and regulatory requirements.Prior experience as a Lead Site Manager, Lead CRA, or equivalent position titleAbility to work in a matrixed environment.To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc).PreferredFamiliarity with Long COVID or chronic disease research.Experience with site performance metrics.Relevant clinical research certifications (e.g., CCRA, CCRP) are preferred but not required.Proven experience managing site start-up, enrollment, and follow up for Phase I-IV clinical trials across multiple therapeutic areas.Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating complex regulatory and ethical processes for clinical trial start-up.Prior experience managing or leading a team and providing mentorship and training to junior colleagues is highly desired.#LI-KV1
