Senior Associate, Operational Excellence

Care Access

6d•$70,000 - $100,000•Remote

About The Position

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. We are seeking an experienced clinical research associate to assist with the operations and strategic growth of our clinical research sites. The ideal candidate brings a strong background in clinical research management, regulatory compliance, and team development, with a proven ability to drive operational excellence and foster a culture of quality. This role requires a proactive, solutions-oriented professional who can balance day-to-day site operations with long-term business development and staff leadership. The successful candidate will ensure compliance with all applicable regulations, assist with study start-up and enrollment efforts, and cultivate an environment where staff thrive, and studies are executed at the highest standards.

Requirements

A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role. CRC experience a plus.
Hands-on knowledge of ICH-GCP, FDA regulations, and local regulatory requirements.
Demonstrated success in study management, study start-up, patient recruitment, and compliance oversight.

Nice To Haves

Budget management, business development, or sponsor/CRO engagement experience is a strong plus.
Bachelor’s degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline).

Responsibilities

Site Operations Management - Assist with daily site activities acting as the primary point of contact for the site, ensuring appropriate staffing, training, and adherence to SOPs. Maintain compliant facilities and equipment.
Leadership & Staff Development: Assist with training and mentoring research staff. Uphold professional development goals and foster a culture of accountability, integrity, and continuous improvement.
Work with Manager, Operational Excellence to ensure high staff morale and low turnover rates
Regulatory & Compliance Oversight: Promote strict adherence to ICH-GCP, FDA, and local regulations, while maintaining audit readiness across all studies.
Assist Manager, Operational Excellence, Operational Compliance, and Quality Assurance Departments with all Care Quality and FDA audits
Business Development: Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits.
Study Start-Up & Enrollment Oversight: Support with regulatory packet submissions, and site initiation processes. Work with investigators to meet or exceed patient recruitment and retention goals.
Assist with additional projects such as quality improvement initiatives, internal data monitoring ensuring accuracy, integrity, and timely entry of study data, and may represent the site at meetings and industry events.