Key Responsibilities and Required Skills for Clinical Compliance Officer

🎯 Role Definition

The Clinical Compliance Officer is a hands-on compliance professional responsible for developing, implementing, and maintaining an effective clinical compliance program across clinical operations and research activities. This role ensures adherence to applicable laws, regulations and standards (FDA, ICH-GCP, HIPAA, ISO where applicable), designs and executes internal audits and inspections, leads investigations and corrective action plans, partners with clinical teams to mitigate risk, and provides training and guidance to embed a culture of compliance across the organization. The ideal candidate blends regulatory knowledge, clinical research experience, audit capability, and strong stakeholder communication to reduce regulatory risk and support high-quality clinical research.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator / Clinical Research Associate
Compliance Analyst / Quality Analyst
Regulatory Affairs Associate

Advancement To:

Compliance Manager / Clinical Compliance Manager
Director, Clinical Quality & Compliance
Head of Regulatory Affairs or VP, Quality & Compliance

Lateral Moves:

Quality Assurance Manager
Regulatory Affairs Specialist
Patient Safety / Pharmacovigilance Lead

Core Responsibilities

Primary Functions

Develop, implement and maintain a risk-based clinical compliance program that ensures clinical operations and research activities meet applicable federal and international regulations (FDA, ICH-GCP), institutional policies, and industry best practices.
Plan, lead and execute GCP-focused internal audits and readiness assessments of clinical sites, internal study teams, vendors and CRO partners; document findings, prepare formal audit reports and present results to senior leadership.
Manage inspection readiness activities for regulatory agency inspections (FDA, EMA, other national authorities), including document preparation, mock inspections, inspection response coordination and post-inspection remediation tracking.
Design, review and maintain Standard Operating Procedures (SOPs), policies, and controlled documents related to clinical compliance; ensure version control, distribution, staff acknowledgment and periodic review to maintain currency and regulatory alignment.
Lead investigations into compliance incidents, protocol deviations, serious breaches and data integrity issues; conduct root cause analyses, draft corrective and preventive action (CAPA) plans, monitor effectiveness and close out remediation efforts.
Provide proactive regulatory and compliance guidance to protocol teams, clinical operations, biostatistics, safety, and product development teams on study design, informed consent, data collection, monitoring plans and safety reporting to reduce compliance risk.
Oversee the clinical trial master file / electronic Trial Master File (TMF/eTMF) governance and quality: perform periodic reviews, gap remediation, retention and inspection-ready organization of essential documents.
Coordinate HIPAA and patient privacy compliance for clinical research activities: perform risk assessments, manage data use agreements, and advise on de-identification, limited data sets and appropriate handling of protected health information (PHI).
Establish and track compliance KPIs and dashboards (audit findings, CAPA status, training completion, inspection outcomes) to report program performance to senior management and the board as needed.
Manage vendor and CRO oversight program including qualification, contract review to include compliance obligations, periodic monitoring, audits, and escalation of vendor non-conformances.
Design and deliver targeted compliance training curricula for clinical staff, investigators, monitors, and remote teams on GCP, informed consent, safety reporting, data integrity and study-specific compliance requirements.
Review and advise on informed consent processes, patient recruitment materials and communication to ensure regulatory, ethical and institutional review board (IRB) compliance.
Support safety and pharmacovigilance teams on regulatory reporting obligations, ensuring timely expedited reporting, reconciliation of safety datasets, and documentation of safety-related compliance activities.
Lead or participate in cross-functional compliance risk assessments for new protocols, technologies (e.g., eConsent, remote monitoring, digital endpoints) and partnerships to identify regulatory gaps and build mitigation plans.
Review clinical contracts, subawards and site agreements for compliance clauses, indemnity, data protection, records retention and audit rights; escalate and negotiate terms with legal and procurement teams.
Maintain up-to-date expertise on evolving regulatory guidance, industry standards and enforcement trends (FDA guidance documents, ICH updates), interpreting impact for clinical programs and updating internal policies accordingly.
Coordinate with IT and security teams to ensure systems used in clinical research (EDC, eTMF, CTMS) meet validation, access control, audit trail, 21 CFR Part 11 (where applicable) and data integrity requirements.
Support IRB/ethics committee interactions, providing documentation and responses for study approvals, amendments, continuing review and reportable events.
Facilitate cross-functional investigations into potential research misconduct or noncompliance, collaborating with legal, HR and institutional leadership to ensure appropriate governance and confidentiality.
Drive continuous improvement of the quality management system (QMS) as it relates to clinical compliance, including lessons learned, process standardization, and automation opportunities to reduce manual compliance burden.
Prepare and submit compliance-related reports and documentation for leadership, sponsors, and external stakeholders; maintain accurate, audit-ready records of compliance activities and decisions.

Secondary Functions

Support post-market clinical follow-up or registry compliance activities to ensure ongoing regulatory alignment and capture of real-world safety/effectiveness data.
Contribute to business development reviews by assessing compliance risk for potential collaborations, clinical partnerships and vendor selections.
Participate in cross-functional project teams to advise on compliance implications of novel study designs, decentralized trial components and digital health integrations.
Partner with HR to advise on role-specific compliance responsibilities, onboarding training and performance metrics for clinical staff.
Support ad-hoc regulatory intelligence requests and prepare summaries of new guidance or enforcement actions relevant to clinical development.
Assist with budget planning for compliance activities including audit resource allocation, external consultants and training needs.
Mentor junior compliance staff and provide subject-matter expertise to investigators and study teams on complex compliance questions.
Participate in external industry forums, professional organizations, or investigator meetings to benchmark best practices and represent the organization on compliance topics.

Required Skills & Competencies

Hard Skills (Technical)

Deep working knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812 as applicable), EMA guidance and local regulations relevant to clinical research.
Experience conducting and leading internal audits and vendor/CRO audits with documented audit reports and CAPA management.
Practical expertise in regulatory inspection preparedness, mock inspections, and inspection response coordination.
Strong working knowledge of eTMF, EDC, CTMS, clinical databases and system validation concepts including audit trails and 21 CFR Part 11 compliance.
Proficiency in designing and maintaining SOPs, policy governance, controlled document management and document control systems.
Experience with CAPA systems, root cause analysis methodologies (e.g., 5 Whys, Fishbone), and effectiveness checks.
Familiarity with privacy and data protection frameworks (HIPAA, GDPR considerations for clinical research) and ability to manage data transfer agreements.
Track record of supporting safety reporting and expedited notifications in clinical trials and understanding of pharmacovigilance interfaces.
Ability to develop and deliver compliance training programs, educational materials and investigator/site-facing guidance.
Competence in risk assessment methodologies, compliance metrics, KPI dashboards and reporting tools (Excel, Power BI, Tableau or similar).
Experience reviewing clinical contracts, clinical trial agreements and vendor contracts for compliance and audit clauses.
Comfortable using contemporary collaboration tools (JIRA/Confluence, SharePoint) and preparing inspection-ready documentation.

Soft Skills

Strong stakeholder management and influence skills; able to communicate complex regulatory concepts clearly to clinical, legal and executive audiences.
High ethical standards, sound judgment, and the ability to handle sensitive investigations with discretion and confidentiality.
Excellent written communication for drafting policies, audit reports, regulatory responses and training materials.
Detail-oriented with strong organizational skills and the ability to manage multiple compliance projects and deadlines simultaneously.
Analytical thinker with problem-solving mindset and ability to prioritize risk-based activities.
Collaborative and team-oriented; proven ability to partner with cross-functional teams and external partners.
Resilience and adaptability in a fast-paced regulatory environment with shifting priorities.
Coaching and mentoring ability to develop compliance capability across the organization.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Nursing, Life Sciences, Public Health, Health Administration, Regulatory Affairs, or related field.

Preferred Education:

Master’s degree (MPH, MSc Clinical Research, MBA with healthcare focus) or advanced clinical degree (RN, PharmD) plus targeted compliance training.
Professional certifications such as Certified in Healthcare Compliance (CHC), RAC, CCEP, SOCRA/ACRP certifications, or equivalent are highly desirable.

Relevant Fields of Study:

Clinical Research / Clinical Trials Management
Regulatory Affairs / Health Law
Nursing, Pharmacy, Public Health

Experience Requirements

Typical Experience Range:

4–8 years of progressive experience in clinical compliance, quality assurance, regulatory affairs or clinical operations within pharmaceuticals, biotech, CROs, medical device or academic research institutions.

Preferred:

5+ years specifically focused on clinical compliance or quality in a regulated environment with documented experience leading audits, inspections, CAPA programs and SOP governance.
Direct experience supporting FDA/EMA inspections, vendor/CRO oversight, and decentralized/remote trial compliance is a strong plus.