Operational Compliance Manager

About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.

How This Role Makes a Difference

We are currently seeking a dedicated and clinical research experienced professional for the position of Operational Compliance Manager. As an Operational Compliance Manager, you will play a crucial role in supporting the execution of our operational quality and compliance framework at the Research Site level. Your main objective will be to oversee Operational Compliance at the site level ultimately increasing operational quality, efficiency, and long-term business success.

How You'll Make An Impact

• Oversee the accuracy and quality of data for research projects within a designated research site.

• Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site.

• Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.

• Oversee the implementation of best practices within a designated site to pre-empt quality issues.

• Collaborate with the Operational Compliance Team with the management of quality issues reported in the Care Access Quality Management System specific to a designated site.

• Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.

• Complete operational compliance checks on clinical trial records for a designated site ensuring that source data, CRF and ISF records are accurate complete and inspection ready at all times.

• Ensure designated site staff are compliant with regulatory, client and or Sponsor requirements and or expectations

• Brazil-Specific Regulatory & Compliance Responsibilities

• Ensure site-level compliance with local regulations, including maintenance of ethics and regulatory documentation aligned with Brazilian requirements.

• Monitor adherence to LGPD (Lei Geral de Proteção de Dados) requirements in clinical research operations, including participant data handling and documentation practices.

• Operational Risk & Quality Management

• Proactively identify operational and compliance risks specific to Brazilian site operations and escalate trends to the Global Operational Compliance team.

• Lead or support localized Corrective and Preventive Action (CAPA) development and follow-up for site-level deviations and audit findings.

• Support inspection readiness activities tailored to Brazil, including mock inspections and documentation reviews reflecting local regulatory expectations.

• Support site with monitoring follow up letters

• Review and report on trends and issues

• Cross-Functional & Regional Collaboration

• Act as a key liaison between site teams, Global Operational Compliance, and regional leadership to ensure consistent implementation of Care Access quality standards within Brazil.

• Collaborate with Study Operations, Corporate support teams and Investigator teams to align operational practices with both global SOPs and Brazilian regulatory frameworks.

• Provide input into the adaptation of global SOPs and quality tools to ensure operational feasibility within the Brazilian clinical research environment.

• Training & Capability Building

• Support onboarding and continuous training of site staff on GCP, Brazilian regulations, and Care Access operational quality standards.

• Reinforce a culture of quality and inspection readiness through routine coaching, spot checks, and on-the-job guidance.

• Data & Performance Oversight

• Contribute to regional quality and performance reporting, identifying Brazil-specific trends related to data quality, protocol deviations, and inspection findings.

• Support continuous improvement initiatives by using operational metrics to recommend process enhancements at the site level.

The Expertise Required

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.

• knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.

• Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.

 Certifications/Licenses, Education, and Experience:   

• Minimum of 3 years of industry experience

How We Work Together

• Travel: This is a hybrid position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays

• Medical, dental, and vision insurance plan options

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: [email protected]

Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: 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.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.