Operational Compliance Associate

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 Associate. As an Operational Compliance Associate, 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

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 an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%).

• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

Benefits & Perks

• PTO/vacation days, sick days, holidays.

• LuxMed

• PPK Plan

• Life Insurance

• Health & Wellness Allowance

• Car Allowance

• Quarterly bonus system based on achieving individual goals

• Culture of growth and equality

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]