Senior Associate, Operational Excellence
CARE
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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.
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.
- Budget management, business development, or sponsor/CRO engagement experience is a strong plus.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchstudy managementstudy start-uppatient recruitmentcompliance oversightbudget managementbusiness developmentsponsor engagementCRO engagementSOP adherence
Soft skills
leadershipstaff developmentmentoringaccountabilityintegritycontinuous improvementcommunicationteam moraleproblem-solvingorganizational skills