Senior Clinical Research Coordinator

Laborie Medical Technologies Corp•Maple Grove, MN

About The Position

The Senior Clinical Research Coordinator is an experienced clinical operations professional who independently manages complex clinical research activities across multiple studies. The role provides operational leadership for trial master file (TMF) management, payments, and contract administration while driving process improvements, ensuring inspection readiness, and mentoring less experienced team members. The Senior CRC serves as a key liaison among Clinical, Legal, Finance, Quality, and external stakeholders. The position develops and monitors study operational metrics, key performance indicators, and compliance risks, collaborating with study teams to mitigate risks. It leads end-to-end TMF strategy and execution for assigned studies, oversees department payment processes, and manages clinical, vendor/CRO service, consultant, and related agreement administration and timelines. The role also coordinates study- and department-related meetings.

Requirements

Bachelor's degree in Life Sciences, Health Sciences, Business Administration, or a related field, or an equivalent combination of education and experience.
4–6 years of clinical research, clinical operations, TMF management, contract administration, or related experience.
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.
Strong analytical and problem-solving skills.
Ability to identify risks, influence outcomes, and drive process improvements.

Nice To Haves

Medical device, pharmaceutical, or biotechnology industry experience.

Responsibilities

Develop and monitor study operational metrics, key performance indicators, and compliance risks; 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.
Lead and manage contract administration and timelines; identify and mitigate delays and ensure timely execution of clinical, vendor/CRO service, consultant, and related agreements.
Coordinate and support study- and department-related meetings, including developing agendas, preparing materials, and documenting and distributing meeting minutes.
Provide operational leadership across multiple studies and help ensure inspection readiness.
Mentor less experienced team members.
Act as a liaison among Clinical, Legal, Finance, Quality, and external stakeholders.