Senior Clinical Research Quality and Compliance Specialist

Why RTI

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.

About the Hiring Group

RTI seeks a Senior Clinical Research Quality and Compliance Specialist to provide internal leadership and subject matter expertise for FDA-regulated clinical research, including clinical trials conducted under Investigational New Drug applications (INDs). This role will support clinical trial infrastructure and integrate quality and risk management into ongoing study and program operations, including protocol support, monitoring, governance, operational oversight, regulatory compliance, and inspection readiness.

The Specialist will establish, maintain, and continuously improve quality management, risk management, audit readiness, corrective and preventive action (CAPA), vendor and subcontractor oversight, and essential document review processes. The role will provide sustained internal accountability for ensuring a coordinated, compliant, risk-based, and inspection-ready approach across program management, studies, sites, laboratories, vendors, and subcontractors.

The position will primarily support complex FDA-regulated clinical research programs and may provide related quality, regulatory, and risk-management expertise across other RTI clinical, laboratory, and biomedical research activities as needs arise.

What You'll Do

The Senior Clinical Research Quality and Compliance Specialist will serve as an internal subject matter expert and operational lead for clinical research quality, compliance, risk management, and inspection readiness. Key responsibilities include:

1. Quality Oversight and Clinical Trial Infrastructure

• Review and assess quality management processes, standard operating procedures (SOPs), study plans, and operational practices and assist project teams in developing and revising these as needed.
• Support development and implementation of risk-based quality management plans for FDA-regulated clinical trials, aligned with ICH GCP principles, applicable FDA regulations, quality-by-design expectations, participant protection, and reliable trial results.
• Partner with clinical research teams to integrate quality and risk management into protocol development and implementation, study start-up, monitoring, governance, operational management, and ongoing study oversight.
• Provide quality and compliance input to clinical trial governance and oversight structures, including identification of emerging issues, trends, and areas requiring additional monitoring or management attention.
• Review quality issues, protocol deviations, audit findings, and compliance concerns; manage internal CAPA processes for project issues when identified, including root-cause analysis, corrective and preventive action planning, implementation tracking, effectiveness checks, and documentation of closure.

2. Risk Management

• Facilitate identification, assessment, documentation, escalation, and monitoring of clinical trial and program-level risks that could affect participant safety, rights and welfare, data integrity, protocol compliance, regulatory obligations, or reliability of trial results.
• Support development and implementation of risk mitigation and monitoring plans and help project teams incorporate risk management into ongoing trial operations.
• Participate in program and study governance meetings to provide independent assessment of quality, operational, and compliance risks.
• Support project teams with ongoing risk-management oversight of clinical sites, laboratories, vendors, and subcontractors, including identification of risks, assessment of potential impact on trial quality and compliance, escalation of significant risks, tracking of mitigation activities, and oversight of CAPA completion when issues are identified.
• Identify recurring or cross-program quality and compliance risks and recommend practical improvements to strengthen processes, controls, and oversight.

3. Regulatory and Compliance Support

• Advise project teams on interpretation and application of FDA regulations applicable to clinical research and IND clinical trials, including 21 CFR Part 312, sponsor/CRO responsibilities, ICH GCP requirements, and integration of sponsor requirements with internal processes.
• Review program and study oversight documentation, quality records, and compliance records to ensure applicable regulatory obligations, sponsor/CRO responsibilities, protocol requirements, GCP expectations, sponsor requirements, and internal requirements are addressed.
• Provide quality and regulatory guidance to clinical research teams throughout the study lifecycle, including protocol development, study start-up, execution, monitoring, closeout, and preparation for regulatory or sponsor review.
• Assess internal readiness for FDA inspections, sponsor audits, and other quality assessments by identifying preparation gaps, supporting readiness planning, and assisting teams with pre-inspection or pre-audit preparation as needed.
• Plan, conduct, and document quality and compliance audits for FDA-regulated clinical research, including internal process audits, study-level audits, site-related audits as applicable, and targeted audits prompted by identified risks, findings, protocol deviations, regulatory compliance concerns, or data-integrity concerns.
• Develop and conduct risk-based vendor and subcontractor audits for outsourced clinical research activities, including review of contracted responsibilities, applicable SOPs, training records, quality records, data handling, oversight documentation, regulatory compliance, sponsor and program requirements, and processes for issue management and CAPA completion.
• As appropriate, provide regulatory strategy and quality input for early-stage biomedical technologies, including support for stage-appropriate development and Chemistry, Manufacturing, and Controls (CMC) considerations, in collaboration with relevant scientific and regulatory subject matter experts.

4. Clinical Trial Documentation and Essential Document Review

• Review essential clinical trial master file documents for FDA-regulated clinical trials to support inspection readiness, traceability, completeness, and alignment with GCP, protocol, sponsor, and applicable regulatory requirements.
• Provide independent review of site essential documents, including site-selection and start-up documentation.
• Advise on electronic Trial Master File (eTMF) quality-control processes and related documentation practices.
• Provide quality and compliance review of IND-related regulatory submissions and supporting documentation, as applicable, with attention to consistency, traceability, inspection readiness, and alignment with study conduct.
• Support development and maintenance of practical tools, templates, trackers, dashboards, and other resources that enable consistent quality and risk oversight across clinical research programs.

What You'll Need

Education and Experience Requirements:

Bachelor’s degree and at least 12 years of relevant experience, or a Master’s degree and at least 10 years of relevant experience, or a PhD and at least 6 years of relevant experience, or an equivalent combination of education and experience.

Relevant experience should include substantial hands-on experience supporting, overseeing, managing quality for, or auditing FDA-regulated clinical research. Experience with clinical trials conducted under an IND is required.

Required Knowledge, Skills, and Abilities:

• Demonstrated expertise in FDA-regulated clinical research, including applicable FDA regulations, ICH GCP, sponsor/CRO responsibilities, clinical trial oversight, quality-management systems, participant protection, data integrity, and regulatory compliance.
• Experience supporting sponsors, CROs, coordinating centers, clinical research networks, sites, laboratories, vendors, subcontractors, or complex multi-site clinical trial programs.
• Experience integrating quality and risk management into clinical trial planning and operations, including protocol implementation, monitoring, governance, and operational oversight.
• Experience with risk-based quality management, FDA inspection readiness, GCP audits, CAPA management, and vendor/subcontractor quality oversight.
• Experience supporting FDA-regulated IND clinical trials and complex or multi-site clinical research programs.
• Strong judgment, communication, and influencing skills, with the ability to identify and appropriately escalate quality or compliance concerns while partnering constructively with project and scientific teams.
• Ability to operate independently as a senior subject matter expert while collaborating effectively across multidisciplinary and matrixed teams.
• Ability to develop practical SOPs, templates, tools, trackers, dashboards, audit plans, CAPA documentation, and inspection-readiness materials for complex clinical research environments.
• Ability to translate regulatory and quality requirements into practical approaches that support effective research operations.
• 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.).  

Preferred Qualifications:

• Experience providing clinical quality, compliance, or risk-management leadership within a sponsor, CRO, coordinating center, academic research organization, clinical trial network, or similar research environment.
• Experience preparing teams for FDA inspections or sponsor audits and responding to inspection, audit, or quality-assessment findings.
• Experience establishing or strengthening cross-program quality infrastructure, including SOPs, audit programs, CAPA workflows, vendor-oversight models, monitoring approaches, and inspection-readiness practices.
• Experience supporting early-stage biomedical product development or providing regulatory or quality input related to CMC strategy.
• Experience applying clinical research quality and compliance expertise to laboratory-based or translational research environments.
• Relevant quality, clinical research, regulatory, project-management, or auditing certification.

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EEO & Pay Equity Statements

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.

Hiring Salary Range