Senior Clinical Research Coordinator

Laborie; Minnetonka (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

401k with company match

Parental Leave

Health Savings Account

Wellness programs

Job summary

Laborie is seeking a Senior Clinical Research Coordinator to independently manage complex clinical research activities across multiple studies. You will lead TMF strategy, oversee payments and contracts, and mentor junior team members while coordinating with Clinical, Legal, Finance, and Quality teams.

The role requires strong knowledge of ICH-GCP and TMF requirements, plus experience in clinical study documentation and cross-functional collaboration.

Qualifications

• 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 skills.
• Ability to identify risks, influence outcomes, and drive process improvements.

Responsibilities

• Develop and monitor study operational metrics, key performance indicators, 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.
• Monitor payment compliance, forecasting, tracking, and reconciliation activities.
• Lead and manage administration and timelines, proactively 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.

Skills

ICH-GCP knowledge

TMF requirements

Contract administration

Stakeholder management

Analytical skills

Organizational skills

Risk identification

Problem-solving

Education

Bachelor's degree in Life Sciences, Health Sciences, Business Administration, or related field

Tools

eTMF systems

contract tracking tools

Microsoft Office

Job description

We believe that great healthcare is an essential safeguard of human dignity. A t Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the Clinical team, the Senior Clinical Research Coordinator services as an experienced clinical operations professional responsible for independently managing complex clinical research activities across multiple studies. The Senior CRC 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 acts as a key liaison among Clinical, Legal, Finance, Quality, and external stakeholders.

About the Role:

• 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.
• Monitor payment compliance, forecasting, tracking, and reconciliation activities.
• Lead and manage administration and timelines, proactively 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.

Minimum Qualifications:

• 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 skills.
• Ability to identify risks, influence outcomes, and drive process improvements.

Why Laborie:

• 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

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.