Clinical Research Associate Jobs

We believe that great healthcare is an essential safeguard of human dignity.

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.

If you share our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion, and are looking to contribute and grow in a fast-paced environment, join us to enhance our customer experience with dignity, at the heart of everything.

Laborie Medical Technologies is currently searching for a Clinical Research Associate to join our team in the Minnetonka, MN office on a hybrid basis (1-2x/week.)

Position Overview:

The Clinical Research Associate will perform tasks related to execution of clinical studies. This person will provide support for essential daily clinical study activities. This person will work with study teams, Clinical Research Organizations (CROs), and investigational sites to support clinical study activities. This person will also support generating and maintaining required post-market surveillance (PMS) and clinical evaluation activities (plans and reports) in accordance with relevant standards and Laborie standard operating procedures.

How you contribute:

• Supports post-market clinical plan activities, including physician surveys, retrospective and/or prospective studies etc.
• Support cross-functional teams in responding to requests from competent authorities, registries and notified body.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• May serve as the clinical representative on a New Product Development team.
• Perform other duties assigned as needed.
• Experience supporting clinical trials in all phases (start-up, conduct, and closeout) including activities such as protocols, informed consent, case report forms, site management (initiation & training), monitoring, device accountability, etc.)
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
• Oversee activities related to the start-up, conduct and closeout of clinical studies according to regulations (i.e., Good Clinical Practice, ISO14155, etc.) and Laborie SOPs.
• Create and maintain PMS documents to ensure compliance with applicable regulatory requirements and guidance’s (i.e., MDCG).

Qualifications:

• Degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry, Engineering or another related technical field is preferred.
• Well organized and able to multitask effectively.
• Good written and verbal communication, problem-solving, and critical thinking skills.
• 3-5 years of relevant CRA work experience with medical device
• Experience with or exposure to Good Clinical Practices.
• Understanding of the domestic and international requirements for post-market surveillance such as ISO 13485/14971, FDA Regulations (21 CFR (803, 806, etc.), CMDR, MDD and EU MDR.
• Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.

How we take care of you:

• Company-paid short-term and long-term disability and Basic Life and AD&D
• Health Savings Account and Flexible Spending Account
• Paid holidays
• 401k Retirement Plan with Company Match
• Medical, Dental, Vision, and Employee Wellbeing programs
• Flexible work schedule and environment
• Parental Leave and Adoption Services
• Paid time off and Volunteer time

Laborie is a specialty manufacturer and supplier of medical technologies and devices, committed to excellence in diagnostics and therapeutics for Urological, Gastrointestinal, Obstetric, Gynecological, and Neonatal healthcare and committed to equal employment opportunity 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.

www.laborie.com