Laborie Medical Technologies Corp
Senior Clinical Research Associate
TLDR
Responsible for comprehensive site management across all phases of clinical trials, ensuring compliance with regulatory requirements and driving patient enrollment and site performance.
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:
The Senior Clinical Research Associate is responsible for monitoring and site management activities to ensure timelines and deliverables are met at assigned sites. Proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. Engages with study investigators, vendors, and internal/external stakeholders as a member of the Clinical Research Team. Build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP, ISO14155, and Laborie SOPs. Focus on subjects’ rights, safety, and well-being and to ensure high quality data.
About the Role:
Responsible for comprehensive site management across all phases of clinical trials in compliance with Laborie SOPs, ICH-GCP, and local regulations. Key duties include:
- Oversee site selection, initiation, monitoring, and close-out visits per study protocols and regulatory guidelines.
- Develop and manage trial documentation (e.g., protocols, ICFs, CRFs, monitoring plans, site tools).
- Lead site feasibility, identification, and selection activities.
- Coordinate internal training and maintain study personnel records.
- Ensure timely reporting and follow-up of AEs/SAEs and protocol deviations.
- Present at Investigator Meetings.
- Serves as a study liaison with internal teams and vendors.
- Drive patient enrollment and site performance to meet recruitment goals.
- Conduct data reviews and support Risk-Based Monitoring activities.
- Serve as primary site contact and ensure proper handling of investigational products and other study supplies.
- Support the execution of study committee meetings (e.g., DMC, CEC, publication).
- Provide support for technical documentation (e.g., PMS, PMCF, CER, CEP), as needed.
Minimum Qualifications:
- Bachelor’s degree in life sciences, medicine, or similar discipline.
- Minimum of six (6) years of industry experience in clinical research or equivalent experience gained with a CRO, pharmaceutical or medical device company.
- Thorough knowledge of ICH/GCP Guidelines, ISO 14155, and FDA and EU MDR, including a basic understanding of regulatory requirements in other countries.
- Advanced site monitoring skills.
- Ability to work with minimum supervision, excellent task management skills and collaboration, including verbal and written communication.
- Ability to travel (5-10%) domestically and internationally on an as-needed basis with advance notice.
- Knowledge of MS Office and clinical trial management systems.
- Full working proficiency in English.
Preferred Qualifications:
- Experience with interventional urology, urology, obstetrics, or gastroenterology medical devices.
- Experience with global clinical projects
- ACRP or SOCRA certification.
- Advanced site monitoring skills.
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
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.
Benefits
Equity Compensation
401k Retirement Plan with Company Match
Health Insurance
Medical, Dental, Vision and Flexible Spending Account
Home Office Stipend
Health Savings Account with Company Funded Contributions
Paid Parental Leave
Parental Leave and Adoption Services
Paid Time Off
Paid time off and paid volunteer time
Wellness Stipend
Health and Wellness Programs and Events
Laborie Medical Technologies Corp develops and advances specialized medical technologies focused on preserving and restoring human dignity. Their innovative solutions cater to healthcare providers, aiding in safe deliveries and the treatment of pelvic and gastrointestinal conditions.
Clinical Research Associate