Oversight CRA

Description

• Collaborate with cross-functional teams (Clinical Operations, Data Management, QA, and Vendor Management) to support continuous improvement.
• Verify that CROs and CRAs follow appropriate risk identification and mitigation measures.
• Support root cause analysis and CAPA development related to monitoring or site performance.
• Participate in oversight governance meetings and contribute to vendor performance reviews.
• Perform remote and on-site oversight visits to evaluate CRA performance and site quality.
• Provide feedback and guidance to CRO CRAs regarding quality expectations, data integrity, and GCP compliance.
• Track and trend CRO performance metrics and KPIs; identify systemic issues and areas for improvement.
• Contribute to development and maintenance of risk-based Monitoring Oversight Plan.
• Review monitoring visit reports, follow-up letters, issue logs, and escalation processes to assess adequacy and timeliness.
• Ensure site inspection readiness and participate in inspections or audits as required.
• Build trusted partnerships with investigators and site staff to enhance collaboration and ensure site needs are recognized and met.
• Implement risk-based quality oversight strategies in alignment with the sponsor’s Monitoring Oversight Plan and Quality Risk Management Plan.
• Maintain oversight documentation, Monitoring Oversight Visit reports, and issue-tracking logs per sponsor SOPs.
• Evaluate protocol-specific risks related to patient safety, data quality, and site operations.
• Serve as the primary liaison between study sites and the sponsor.
• Provide continuous oversight of CRO-conducted monitoring activities to ensure compliance with the study protocol, Monitoring Plan, SOPs, regulatory and GCP requirements.
• Prepare and deliver periodic oversight summaries for leadership review.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (advanced degree preferred).
• Demonstrated experience in inspection readiness and CAPA management.
• Experience overseeing eCOA vendor preferred.
• Minimum 2 years of hands-on Monitoring Oversight experience including on-site monitoring oversight visits.
• Strong analytical, documentation, and communication skills.
• Excellent communication, organizational, and problem-solving abilities.
• Prior experience in CRO/vendor management or QA auditing is strongly preferred.
• Minimum 5–7 years of clinical research experience, including at least 3 years of on-site monitoring.
• Experience with Veeva Vault CTMS.
• Neurology experience preferred.
• Thorough understanding of ICH-GCP, E6 R2/R3, and applicable regional regulations.
• Ability to travel for oversight visits (50–70%).

Benefits

• Health Spending Account (HSA)
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Dec 31, 2025.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Medical, dental & vision
• Employee Assistance Program
• Short and long-term disability

Training + Development

Interview process

Visa Sponsorship

Security clearance