Care Access · 2 months ago
Senior Associate, Operational Excellence
United States
Full-time
Remote
Senior Level
5+ years expCare Access is dedicated to improving health services globally and is seeking a Senior Associate in Operational Excellence. This role focuses on managing clinical research site operations, ensuring compliance with regulations, and fostering staff development to drive operational excellence.
Clinical TrialsHealth Care
No H1B
Responsibilities
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
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
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
Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits
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
Qualification
Required
A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role
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
An equivalent combination of education and direct clinical research leadership experience may be considered in place of formal degrees
Preferred
Bachelor's degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline)
Benefits
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
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
2026-01-23
Company data provided by crunchbase