Senior Clinical Research Coordinator

Laborie Medical Technologies Corp

$80K — $100K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Health Sciences, Business Administration, or related field, or equivalent experience.
  • 4-6 years in clinical research or clinical operations, with a preference for medical device, pharmaceutical, or biotech experience.
  • Experience managing clinical study documentation and operational processes independently.
  • Demonstrated leadership in complex operational activities with minimal supervision.
  • Strong grasp of ICH-GCP, TMF requirements, and clinical research regulations.
  • Proficiency in eTMF systems, contract tracking tools, and Microsoft Office applications.
  • Excellent organizational, communication, and stakeholder management skills.

Responsibilities

  • Develop and track operational metrics, key performance indicators, and compliance risks for studies.
  • Participate in initiatives to enhance operational efficiency and quality.
  • Lead TMF strategy and execution for assigned studies.
  • Oversee payment processes for studies, ensuring compliance and tracking.
  • Manage administration and timelines, proactively identifying and mitigating delays.
  • Coordinate and support meetings with agenda creation, material preparation, and documentation of minutes.

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.
  • Cigna Healthy Workforce Designation Gold Level award.
Full Job Description
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: Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries. • 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

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