CLINICAL QUALITY SPECIALIST JOB DESCRIPTION

A Clinical Quality Specialist is the practitioner who keeps early-phase and registrational clinical trials audit-ready - reviewing Trial Master File documentation, tracking CAPAs through resolution, and representing the quality function when FDA BIMO inspectors arrive. The role reports into R&D Quality or the CMO office and owns the audit cycle from schedule through closeout. What makes it demanding is the scope: one specialist may simultaneously manage CRO performance metrics, support gap analyses against 21 CFR Parts 50, 54, 56, and 812, and maintain the compliance posture of studies across multiple therapeutic programs.

As the Clinical Quality Specialist, you ensure that clinical trials conducted in support of pharmaceutical and medical device registrations remain in continuous compliance with GCP regulations, applicable FDA requirements, and ISO standards throughout the audit and CAPA lifecycle. You work across Clinical Development, Regulatory Affairs, and external CRO partners, with oversight from the Chief Medical Officer or Quality leadership depending on organizational structure.

Career Impact: Managing FDA BIMO inspections and authoring audit reports against 21 CFR and ISO 14155 builds a compliance credential that is recognized across pharmaceutical, biotech, and medical device sponsors.

Business Impact: When CAPA resolution stalls or TMF documentation gaps go undetected, registration timelines slip - this role prevents those delays by owning the quality infrastructure that keeps studies on track.

Growth Opportunity: Specialists who develop lead auditor standing and cross-functional CRO oversight experience are well-positioned to move into Clinical Quality Manager or Director of Quality Assurance roles.

Company Value: Roles in this group offer remote and virtual work arrangements, reflecting the distributed nature of multi-site clinical trial oversight.

• Maintain audit schedules, audit records, and CAPA tracking to ensure all commitments are closed on time.
• Conduct TMF audits for early-phase and registrational clinical studies, verifying documentation meets applicable standards.
• Perform gap analyses of clinical SOPs and study documentation, producing clear written reports of findings and remediation recommendations.
• Support site and CRO audits as lead or co-auditor, compiling all documentation for post-audit analysis.
• Develop and track CRO performance metrics to surface emerging quality trends before they become regulatory findings.
• Collaborate with Regulatory Affairs staff to confirm that vendor agreements and contracts are in place and current.
• Partner with Operations staff on root cause analysis for Quality Issues, ensuring corrective actions are risk-based and effective.
• Serve as the primary internal liaison with quality consultants, managing agreement logistics and account payables for the CQA function.

• Bachelor's degree in life science, a related field, or equivalent work experience.
• Two or more years of experience in clinical quality, regulatory compliance, or a related pharmaceutical or medical device role, with direct exposure to GCP-regulated environments.
• Working knowledge of GCP regulations and guidelines including ICH E6, US FDA requirements, and ISO 14155.
• Familiarity with 21 CFR Parts 11, 50, 54, 56, and 812, and the ability to assess study compliance against those frameworks.
• Demonstrated ability to develop and implement risk-based corrective and preventive actions.
• Strong written and verbal communication skills, with the ability to produce audit reports that are accurate, concise, and defensible.
• Ability to maintain strict confidentiality across all study and sponsor data.
• Proven organizational skills, including the ability to manage concurrent audit cycles and shifting deadlines without loss of accuracy.

• Advanced degree in life science, clinical research, regulatory affairs, or a related discipline.
• Auditor certification such as ASQ CQA, ASQ CBA, or equivalent GCP auditor credential.
• Prior experience supporting or participating in FDA BIMO inspections, including back-room coordination.
• Experience working in a remote or distributed team environment spanning multiple clinical sites or CRO relationships.

• CAPA closure rate within committed timelines, reflecting the specialist's ability to drive corrective action to completion.
• TMF completeness score at time of audit, measuring how thoroughly study documentation is maintained before external review.
• Audit finding repeat rate across consecutive cycles, indicating whether root cause analyses are producing durable fixes.
• CRO performance metric trends over rolling quarters, showing whether vendor quality issues are being identified and addressed proactively.
• Time from audit closeout to final report distribution, reflecting documentation turnaround discipline.
• Typical tools: Clinical quality management systems (commonly Veeva Vault, CQMS); document management platforms; audit tracking software.

• Base Salary Range: $75,000 to $105,000 annually, varying by seniority and location.
• Bonus: 5% to 10% annual target, tied to individual and departmental performance.
• Equity: stock options or RSUs common at biotech and early-stage pharma sponsors.
• Health Benefits: medical, dental, and vision coverage standard; HSA options common.
• PTO: 15 to 20 days annually, plus company holidays.
• Common Perks: Remote or hybrid flexibility, professional development funding, and conference attendance support.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Employment contingent on successful completion of a background check. All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the hiring process and in the performance of job duties upon request. Candidates must be authorized to work in the United States.

The Clinical Quality Specialist owns the monthly and quarterly audit cycle for medical review staff, delivering findings, trend analysis, and training to Medical Review management to strengthen quality and consistency across government and commercial payer programs. Reporting to Medical Review management, the role shapes compliance with HIPAA Privacy and Security Rules and CMS requirements while collaborating with the Medical Director and department leadership to resolve disputes and build staff capability.

Key Responsibilities

• Audit clinical work of medical review staff for quality on a monthly basis and consistency on a quarterly basis.
• Provide feedback to medical review staff on audit results.
• Involve Medical Director and department management as needed to resolve disputes regarding audit results.
• Report audit results to Medical Review management monthly, including trends or patterns noted in audit findings.
• Work with Medical Review management to develop training materials based on audit findings and analysis.
• Present training to staff as assigned by Medical Review management.
• Participate in and contribute to the quality management system.

Required Qualifications

• Working knowledge of HIPAA Privacy and Security Rules and CMS security requirements.
• Working knowledge of sampling techniques to validate audit samples.
• Strong quality management experience including TQM or ISO.
• Working knowledge of Microsoft Office, Internet, and email.
• Excellent written and verbal communication skills including public speaking and human relations.
• Ability to maintain high-quality work while meeting strict deadlines.
• Ability to travel to provide training at other sites.

Embedded within the Clinical Quality and Risk team, the Clinical Quality Specialist delivers administrative and operational support across incident monitoring, clinical governance meetings, and accreditation activities for a national government-owned health information service. Working closely with the Clinical Quality and Risk Lead and both internal and external stakeholders, the role produces reporting, maintains clinical risk and quality improvement registers, and builds the policy and procedural infrastructure that keeps services compliant and accountable.

Core Functions

• Support the Clinical Quality and Risk Lead by monitoring and responding to notifications of incidents, feedback, and complaints.
• Coordinate the Clinical Case Management and reporting function for services.
• Provide administrative support for Clinical Governance meetings including agenda preparation, minute taking, and action logs.
• Track and maintain clinical risk and quality improvement registers.
• Engage with internal and external stakeholders to create and maintain all clinical governance policies and procedures.
• Support internal and external audit and accreditation activities.

Qualifications & Experience

• Tertiary qualification or significant industry experience.
• Minimum 2 years of experience using a database or CRM/case management system.
• Proven experience writing reports, minutes, correspondence, and high-level documentation.
• Proven experience working with sensitive clinical information.
• Experience working to competing deadlines while managing multiple stakeholders.

Reporting to the Chief Medical Officer, the Clinical Quality Specialist builds technical quality support for the Clinical Development team, ensuring that early-phase clinical trial activities and CRO partnerships operate in compliance with Good Clinical Practices and applicable study protocols. Partnering with Regulatory Affairs staff and Operations teams, the role delivers quality evaluations of Trial Master File documentation, manages CAPA implementation, and advances the organization's compliance posture across all provider agreements and study timelines.

Primary Duties

• Provide technical expertise and assistance on Clinical Practices and Trials.
• Review and understand Clinical Trial protocols and requirements established for third-party vendors including service level agreements.
• Perform quality evaluations and reviews of early phase clinical study Trial Master File documentation.
• Manage and track study Quality Issues, supporting Operations staff with root cause analysis and implementing CAPAs.
• Work with Regulatory staff to ensure agreements and contracts are in place for all providers.
• Assist with site and provider audits, compiling all documentation for analysis.
• Review audit results, identify findings, and recommend remedial actions to the team.
• Assist management with clinical database maintenance and ensure associated records are in order.
• Track functional project activities to ensure they meet expected timelines and deliverables.
• Advise management of approaching deadlines and flag when additional resources are required.

Skills & Qualifications

• Bachelor's degree in life science or related area required, advanced degree preferred.
• 6 years of experience in clinical quality, clinical supply project management, or a related role in pharma or biotech.
• Advanced knowledge of Microsoft Office Suite.
• Strong written and verbal communication skills with excellent attention to detail.
• Ability to maintain confidentiality at all times.
• Proven ability to work well under pressure in a fast-paced environment with continued process improvement.

Sitting at the intersection of clinical quality assurance and regulatory compliance, the Senior Clinical Quality Specialist leads and supports audits spanning ISO 14155, 21 CFR Parts 11, 50, 54, 56, and 812, and FDA BIMO inspections for a regulated medical device environment. Operating across internal quality programs, client audits, and vendor engagements, the role develops SOPs and corrective action frameworks while advising Clinical Associates, Managers, and project teams on GCP compliance issues.

Duties

• Assist in the development of the internal clinical quality assurance program.
• Support and coordinate in-house, client, and regulatory audits.
• Plan and implement processes for ISO 14155 and 21 CFR Parts 11, 50, 54, 56, and 812 compliance.
• Collaborate on or lead the development of departmental SOPs, work instructions, templates, and forms.
• Lead the back-room during FDA BIMO inspections.
• Participate in the front room during FDA BIMO inspections and defend clinical quality rationale to auditors.
• Conduct vendor audits independently or as lead auditor to determine compliance with GCP regulations.
• Write and distribute audit reports describing audit findings.
• Track audit findings and corrective actions, and document completion of corrective actions.
• Perform gap analysis of clinical studies and clinical SOPs and write clear, concise reports.
• Support clinical study teams and help troubleshoot clinical compliance issues.
• Participate on project teams as extended team member and advise Clinical Associates, Managers, and project teams on GCP compliance issues.

Requirements

• Bachelor's degree or equivalent experience in a related field.
• Auditor Certification preferred, e.g., ASQ CQA, ASQ CBA, or GCP.
• Minimum 3 to 7 years of relevant experience in clinical research or auditing in a regulated medical industry.
• Knowledge and experience with Good Clinical Practices, 21 CFR Parts 11, 50, 54, 56, and 812, ISO 14155, and ISO 13485, ISO 9001, and Part 820.
• Knowledge and experience with Quality System standards and regulations.
• Ability to assess and audit compliance of clinical studies to applicable standards and regulations.
• Ability to develop clinical processes compliant with applicable standards and regulations.
• Solid written and verbal communication skills.

A key member of the clinical quality team, the Clinical Quality Specialist RN leads the identification of patient safety measures, performance improvement planning, and data collection methodology development to drive meaningful change in patient care practices and healthcare delivery. Collaborating across clinical services, medical staff, and department stakeholders, the role draws on active RN licensure and nursing experience to translate quality improvement findings into actionable clinical process change.

Functions

• Identify key clinical quality and patient safety measures.
• Promote the use of appropriate measures for clinical services.
• Use the results of quality improvement activities to initiate changes in patient care practices and healthcare delivery.
• Prioritize and execute performance improvement plans related to clinical performance.
• Perform documentation and process analysis, identify clinical best practices, and work with stakeholders to improve processes.
• Assist with the development, piloting, use, and validation of data collection methodologies.
• Serve as a resource for developing indicators for studies and projects.

Experience & Qualifications

• Bachelor's degree in Nursing.
• State licensure as a Registered Nurse (RN).
• Relevant certification as determined at position level.
• BLS certification through the American Heart Association or American Red Cross CPR for the Professional Rescuer, with card in hand before start date.
• BLS or CPR card must be valid through sixty days after hire.
• All life support certification cards must be issued by the American Heart Association or American Red Cross CPR for the Professional Rescuer.
• 2 years of relevant nursing experience.
• Trauma program or services experience and quality improvement experience.
• Ability to apply critical thinking skills and decisive judgment with minimal supervision.
• Ability to work in a fast-paced environment and take appropriate action.

Accurate, timely registry submission to bodies such as the Joint Commission and CMS depends on the Clinical Quality Specialist, who applies clinical knowledge to interpret metric specifications, abstract EHR data, and maintain high accuracy thresholds across quality data repositories including cardiology and vascular programs. Based within the Quality Department, the role leads data education for peers, team leads, and external stakeholders while navigating electronic medical record systems and supporting smooth departmental operations.

Accountabilities

• Apply clinical knowledge to interpret metric specifications and correctly code registry or abstract case information from the EHR.
• Ensure timely quality submission of all data in specified registries or measure data repositories, maintaining a high accuracy threshold.
• Prioritize and meet deadlines for multiple concurrent tasks and team requests.
• Navigate new technical systems and EMR and registry entry tools.
• Acquire an intermediate level of knowledge for reporting, analysis, and data use from various databases.
• Provide information support to medical staff, leadership, and department colleagues.
• Work cooperatively with department colleagues.
• Deliver education to peers, team leads, and other stakeholders within and external to the department.
• Perform other duties as assigned to ensure smooth and efficient operations within the Quality Department.

Technical Qualifications

• Associate's degree in Nursing or a related field, or equivalent clinical knowledge and work experience.
• Clinical experience or equivalent healthcare experience.
• Experience navigating electronic medical record systems.
• Previous cardiology experience preferred.
• Experience with Epic preferred.
• Proficiency in Microsoft Office Products including Word, Excel, Outlook, and PowerPoint.

As the Clinical Quality Specialist for Research and Development Operations, this role owns the audit program infrastructure including schedules, records, and CAPA tracking within the CQMS system, ensuring clinical trials supporting pharmaceutical and medical device registrations remain in continuous compliance with applicable regulations. The R&D Quality function relies on this work to maintain TMF audit integrity, develop CRO performance metrics, and manage all quality consultant relationships and account payables.

Activities

• Maintain audit schedules, audit records, and CAPA tracking.
• Support auditees in developing effective, risk-based corrective actions.
• Ensure audits are completed on time.
• Develop and track CRO performance metrics to identify trends and mitigate emerging quality issues.
• Maintain the CQA SharePoint site with audit documentation.
• Conduct TMF audits.
• Serve as primary liaison with quality consultants and facilitate all business aspects of consultant agreements and account payables.

Position Requirements

• BS/BA in a related field.
• Minimum 2 years of experience in a related healthcare, medical device, or pharmaceutical industry role.
• Working knowledge of GCP regulations and guidelines including ICH, US FDA, and ISO.
• Strong computer skills.
• Excellent verbal and written communication skills.
• Ability to work effectively on teams.
• Excellent organizational skills.