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About the role
- Operational Compliance Manager at Care Access overseeing quality data for clinical trials at research sites. Ensuring compliance with local regulations and operational excellence in Brazil.
Responsibilities
- 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
- 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.
- 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
- 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.
- 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.
- 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.
Requirements
- 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.
Benefits
- Paid Time Off (PTO) and Company Paid Holidays
- Medical, dental, and vision insurance plan options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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