Senior Clinical Research Associate

Laborie Medical Technologies Corp•Minnetonka, MN

14h

About The Position

Laborie is a world-class specialist medical company dedicated to making and advancing technologies that preserve and restore human dignity, particularly for patients with pelvic and gastrointestinal conditions and for safe deliveries. The company fosters an environment that encourages a sense of belonging and growth, guided by values such as Aspire to Greatness, Respect All, Own It, Working Together, and Persist with Passion. The Senior Clinical Research Associate is responsible for comprehensive monitoring and site management activities to ensure clinical trial timelines and deliverables are met at assigned sites. This role involves proactively identifying and resolving clinical project issues, participating in process improvement initiatives, and collaborating with study investigators, vendors, and internal/external stakeholders as a key member of the Clinical Research Team. The Senior CRA is expected to build and maintain strong relationships with clinical sites and investigators, assessing protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP, ISO14155, and Laborie SOPs, with a primary focus on subjects’ rights, safety, and well-being, and ensuring high-quality data.

Requirements

Bachelor’s degree in life sciences, medicine, or similar discipline.
Minimum of six (6) years of industry experience in clinical research or equivalent experience gained with a CRO, pharmaceutical or medical device company.
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.

Nice To Haves

Experience with interventional urology, urology, obstetrics, or gastroenterology medical devices.
Experience with global clinical projects.
ACRP or SOCRA certification.
Advanced site monitoring skills.

Responsibilities

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).
Lead site feasibility, identification, and selection activities.
Coordinate internal training and maintain study personnel records.
Ensure timely reporting and follow-up of AEs/SAEs and protocol deviations.
Present at Investigator Meetings.
Serve 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.