Senior Clinical Research Associate at Laborie… · Minnetonka

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 Maternal & Child Health Clinical Affairs team, the Senior Clinical Research Associate will play a critical role in advancing medical devices from concept through commercialization. This individual is primarily responsible for supporting new product development (NPD) teams, and providing clinical research leadership in evidence generation to meet regulatory and commercialization needs. The Sr. CRA partners cross-functionally with R&D, Regulatory Affairs, and Commercial teams by contributing to design reviews, risk management, and clinical strategy planning. Additionally, the Sr. CRA will support monitoring and site management activities to ensure timelines and deliverables are met for assigned projects with a focus on subjects’ rights, safety, and well-being and to ensure high quality data.

About the Role:

Responsible for serving as the Clinical Affairs representative for new product development teams, a leader in the development of evidence generation, and comprehensive site management across all phases of clinical trials in compliance with Laborie SOPs, ICH-GCP, and local regulations. Key duties include:

• New product development Clinical Affairs representative, contributing to product design reviews, risk management, and clinical strategy planning.
• Support design verification and validation studies.
• 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).
• 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.

What you Bring:

• Bachelor’s degree in life sciences, medicine, or similar discipline.
• Minimum of 6 to 8 years of industry experience in clinical research or equivalent experience gained with a CRO, pharmaceutical or medical device company.
• Experience contributing to cross-functional new product development teams throughout the development lifecycle with demonstrated experience generating clinical evidence strategies.
• 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, maternal and child health, or gastroenterology medical devices.
• Experience with global clinical projects
• ACRP or SOCRA certification.

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
• Pension Plan
• 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.