Clinical Site Assistant, Clinical Studies

RTI 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.

RTI International, an independent nonprofit research institute dedicated to improving the human condition, is seeking a Clinical Site Assistant to oversee all aspects of clinical site management across the full study lifecycle-from site identification and feasibility through start-up, maintenance, and study closeout. This role is critical to ensuring that sites are properly qualified, activated, supported, and maintained to meet study timelines and quality standards.

The ideal candidate will have hands-on experience in site management and clinical operations, strong knowledge of regulatory and GCP requirements, and the ability to support collaborative relationships with investigators, site personnel, and internal stakeholders to ensure successful site performance throughout the study.

Essential Duties

Site Identification, Feasibility & Selection

• Assist with the coordination of site identification and feasibility assessments, ensuring selection of qualified sites aligned with protocol and sponsor requirements.
• Participate in evaluating sites' patient recruitment capabilities, operational capacity (e.g. facilities, staffing, etc.), and compliance readiness.
• Support and maintain relationships with site investigators, research coordinators, and their respective institutions to execute current and future studies.

Site Start-Up

• Manage components of the start-up activities, including confidentiality agreements, feasibility questionnaires, regulatory document collection, and IRB/IEC submissions.
• In collaboration with relevant cross-functional teams (e.g. contracts/finance, protocol management, etc.), assist senior site managers in the contract negotiation and site budget development and review process.
• Collaborate with regulatory and clinical teams to secure timely approvals and readiness for patient enrollment, under the supervision of senior site managers.
• Assist in tracking and driving completion of essential start-up milestones (e.g., contracts, IRB/IEC approvals, essential documents).

Site Management & Maintenance

• Serve as the primary point of contact for assigned sites for components of the study lifecycle, ensuring consistent communication and support.
• Assist in the monitoring of site performance metrics (enrollment, data entry, protocol adherence, query resolution, etc.) and develop action plans to address issues or delays.
• Facilitate ongoing training, support, and relationship management to promote site engagement and compliance.
• Support senior site managers to partner with the Clinical Monitoring team to ensure resolution of site-level findings and maintenance of quality standards.

Site Closeout

• Oversee components of site closeout activities, ensuring all essential documents are collected and archived in compliance with regulatory and sponsor requirements.
• Assist in the reconciliation of outstanding data, queries, and safety reporting prior to site closure.
• Assist in the preparation of closeout communications with sites to ensure understanding and completion of post-study obligations.

Process Improvement & Compliance

• Identify opportunities to enhance site management workflows, tools, and communication processes/procedures.
• Ensure compliance with ICH-GCP, FDA, EMA, and institutional requirements is maintained throughout all study/site stages.
• Support the development and refinement of SOPs, templates, and training materials to promote operational excellence.

Collaboration & Reporting

• Partner cross-functionally with Clinical Operations (Protocol Management), Regulatory, Contracts and Finance, Statistics and Data Management, Technology and Infrastructure, and Project Management/Leadership teams to ensure alignment on timelines and deliverables.
• Assist with regular updates and risk assessments related to site performance, timelines, and quality.
• Contribute to study-level planning and strategy discussions related to site management and trial execution.

Typical Education & Experience Requirements

• 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 1 year of experience in clinical trials with a focus on site management, start-up, or clinical operations within a CRO, pharmaceutical, or biotechnology company.
• Demonstrated experience supporting site relationships and performance across all study/site stages.
• Experience with regulatory submissions, IRB/IEC submissions, and site initiation processes is essential.
• Familiarity with components of clinical trial management systems (CTMS), electronic Trial Master File (eTMF) and electronic data capture (EDC) platforms.

Skills & Abilities

• Comprehensive understanding of clinical trial processes and GCP/regulatory requirements across the study lifecycle.
• Strong project management and organizational skills with the ability to balance multiple priorities and timelines.
• Excellent interpersonal and communication skills, fostering collaborative and professional relationships with internal teams and external partners.
• Analytical and problem-solving abilities to identify risks and develop practical, compliant solutions.
• Detail-oriented, proactive, and committed to delivering high-quality results.

#LI-KV1

For 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.