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CARE

We work to fight poverty and achieve social justice by empowering women and girls. www.CARE.org

Senior Associate, Operational Excellence

OperationsOperationsFull TimeRemoteSeniorTeam 5,001-10,000Since 1945H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

98 days ago

Salary

$70K - $100K / year

Seniority

Senior

Bachelor Degree5 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

Senior Associate, Operational Excellence

CARE

• 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.

Job 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

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