The Role
Independently manages complex clinical research activities across multiple studies, including TMF strategy, study payments, contract administration, operational metrics, compliance risks, and inspection readiness. Leads process improvements, coordinates clinical and vendor agreements, supports study meetings, and mentors team members. Collaborates with Clinical, Legal, Finance, Quality, CROs, vendors, and other stakeholders to ensure timely, compliant study execution.
Summary Generated by Built In
We believe that great healthcare is an essential safeguard of human dignity.
At 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:
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
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.
Skills Required
- 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 experience in clinical research, clinical operations, TMF management, contract administration, or a related area.
- Medical device, pharmaceutical, or biotechnology industry experience.
- Experience independently managing clinical study documentation and operational processes.
- 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, stakeholder management, analytical, and problem-solving skills.
- Ability to identify risks, influence outcomes, and drive process improvements.
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The Company
What We Do
Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
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