Job Description

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 Clinical Research Associate will perform tasks related to supporting operational strategy and execution of clinical studies. The CRA will provide support for essential daily clinical study activities, including Good Clinical Practice Inspection readiness, following established protocols under the general management of the Clinical Research Manager or designee. The CRA will work with Clinical Research study teams, Clinical Research Organizations (CROs) and investigation sites to support clinical study activities as defined by the clinical trial operating model. This is a hybrid role.

About the Role:

• Support all aspects of study site management for clinical studies according to Laborie SOPs, ICH-GCP, MDR and local regulations to ensure data is up to date per reporting metrics, query resolution, and data entry, including recruitment of potential investigators and sites.
• Develop and maintain strong working relationship with Investigators and study staff, serving as an ambassador to promote Laborie's high quality and ethical image.
• Communicate effectively with site personnel, including the Principal Investigator (PI), troubleshoot and provide appropriate solutions to study-related issues.
• Support site qualification and initiation visits: train Investigators and other trial staff on the protocol and data collection methods to ensure collection of participant data is accurate, complete and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and Laborie SOPs.
• Maintain study tracking in accordance with the demands of the study.
• Monitor and maintain electronic systems for trial management tracking and update study trackers and ensure clinical database accuracy.

Minimum Qualifications:

• Bachelor's degree in Life Sciences.
• 2+ years' experience in medical device or pharmaceutical industry, clinical research organization or related role.
• Knowledge in global regulatory and compliance requirements for clinical research, clinical research processes and regulations, and of FDA CFR (clinical trials), CGPs and ICH Guidance.
• Ability to travel (5-10%) domestic and international on an as-needed basis with advance notice.
• Ability to work with minimum supervision, excellent task management skills and collaboration, including verbal and written communication.

Preferred Qualifications:

• Master's degree in Life sciences
• Experience in Class II medical studies and urology studies
• ACP 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 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 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.

#LI-Hybrid

Job Tags

Full time, Local area, Flexible hours,

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