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:

The Clinical Research Associate II (CRA-II) will perform tasks related to supporting operational strategy and execution of clinical studies, supporting the strategy as defined in the Clinical Affairs Team. Provide support for essential daily clinical study activities, including Good Clinical Practice inspection readiness, following established protocols under the general management of the Clinical Program Manager or designee. 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. Perform departmental tasks as needed.

Responsibilities:

• Assist with site selection, start-up activities, overall study execution for study adherence.
• Conducts all aspects of study site management for clinical studies according to LABORIE Standard Operating Procedures (SOPs), ICH-GCP, MDR and local regulations and to ensure data are up to date per reporting metrics, query resolution, and data entry, including the recruitment of potential investigators and sites.
• Develops and maintains strong working relationship with Investigators and study staff, serving as an ambassador to promote LABORIE high quality and ethical image.
• Communicates effectively with the site personnel, including the Principal Investigator (PI) to troubleshoot and provide appropriate solutions to study-related issues.
• Maintains study tracking, in accordance with the demands of the study.
• Supports completion of monitoring visits per study protocol, monitoring plan, and regulatory guidelines.
• Serve as primary site contact and ensure proper handling of investigational products and other study supplies.
• Support planning and execution activities for study committee meetings (e.g., DMC, CEC, publication)
• Perform other tasks as directed.
• Supports site feasibility, identification, and selection activities.

Minimum Qualifications

• Bachelor's Degree in Life Sciences, medicine, or similar discipline.
• 3-5 years' experience in clinical research or equivalent experience gained with a CRO, pharmaceutical, or medical device company.
• Knowledge of ICH/GCP Guidelines, ISO 14155, and FDA and EU MDR, including a basic understanding of regulatory requirements in other countries
• Ability to work with minimal 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.
• Good verbal and written communication skills.
• Knowledge of MS Office and Clinical Trial Management Systems.

Preferred Qualifications:

• Experience with interventional urology, obstetrics, 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 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.

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Job Tags

Full time, Local area, Flexible hours,

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