Senior Clinical Research Coordinator

About the Role

The Senior Clinical Research Coordinator is a key member of the Clinical team, serving as an experienced clinical operations professional responsible for independently managing complex clinical research activities across multiple studies.

• Develop and monitor study operational metrics, key performance identifiers, and compliance risks as assigned; collaborate with study teams to mitigate risks.
• Participate in departmental initiatives to improve operational efficiency and quality.
• Lead end-to-end TMF strategy and execution for assigned studies.
• Oversee department payment processes for assigned studies, including monitoring payment compliance, forecasting, tracking, and reconciliation activities.
• Lead and manage administration and timelines for clinical, vendor/CRO service, consultant, and related agreements; proactively identify and mitigate delays to ensure timely execution.
• Coordinate and support study- and department-related meetings, including developing agendas, preparing materials, and documenting and distributing meeting minutes.
• Act as a key liaison among Clinical, Legal, Finance, Quality, and external stakeholders.
• Mentor less experienced team members.

Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Business Administration, or a related field, or equivalent combination of education and experience.
• 4-6 years of clinical research, clinical operations, TMF management, contract administration, or related experience; medical device, pharmaceutical, or biotechnology industry experience preferred.
• Experience independently managing clinical study documentation and operational processes.
• Demonstrated ability to lead complex operational activities with minimal supervision.
• Strong knowledge of ICH-GCP, TMF requirements, and clinical research regulations.
• Proficiency with eTMF systems, contract tracking tools, and Microsoft Office applications.
• Advanced understanding of clinical trial documentation, contracts, and payment processes.
• Excellent organizational, communication, and stakeholder management skills with strong analytical and problem-solving abilities.
• Ability to identify risks, influence outcomes, and drive process improvements.

Benefits

• Paid time off and paid volunteer time.
• Medical, Dental, Vision, and Flexible Spending Account.
• Health Savings Account with company-funded contributions.
• 401k Retirement Plan with company match.
• Parental Leave and Adoption Services.
• Health and Wellness Programs and Events.

Awarded 2025 Cigna Healthy Workforce Designation Gold Level.