Senior Associate, Operational Excellence

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 into 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 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. How You'll Make An Impact 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. The Expertise Required 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. Budget management, business development, or sponsor/CRO engagement experience is a strong plus.

Certifications/Licenses, Education, and Experience:

• An equivalent combination of education and direct clinical research leadership experience may be considered in place of formal degrees...this is what I am looking for with the blue wording below.
• Preferred: Bachelor’s degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline).
• Minimum of five years Clinical Research experience.
• How We Work Together
• Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
• Travel: This role requires up to 50% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
• Type of travel required: ​National​
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

Walking - 10% Standing - 10% Sitting - 80% Lifting up to 25 lbs - as needed Driving - as needed Benefits & Perks Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match 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: TalentAcquisition@careaccess.com