Clinical Research Associate II

We believe that great healthcare is an essential safeguard of human dignity. A t Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed 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. Were 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 Were Looking For: As a key member of the Clinical team, the Clinical Research Associate will perform tasks related to execution of clinical studies. The CRA will provide support for essential daily clinical study activities, work with study teams, Clinical Research Organizations (CROs) and investigation sites. The CRA will 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. This is a hybrid role. About the Role:

• 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 guidances (i.e., MDCG).
• 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.
• Support cross-functional teams in responding to requests from competent authorities, registries and notified body.
• 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, and device accountability, etc.
• Supports post-market clinical plan activities, including physician surveys, retrospective and/or prospective studies etc.
• May serve as the clinical representative on a New Product Development team. May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.

Minimum Qualifications:

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

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 2024 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a persons 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.