Senior Clinical Research Associate

Who We're Looking For

We're seeking a Senior Clinical Research Associate who can play a crucial role in advancing medical devices from concept through commercialization. This individual should have a strong background in clinical research or related fields, with experience in new product development and evidence generation.

Responsible For

• Serving as the Clinical Affairs representative for new product development teams
• Contributing to product design reviews, risk management, and clinical strategy planning
• Supporting design verification and validation studies
• Overseeing site selection, initiation, monitoring, and close-out visits per study protocols and regulatory guidelines
• Developing and managing trial documentation (e.g., protocols, ICFs, CRFs, monitoring plans, site tools)
• Cooking internal training and maintaining study personnel records
• Ensuring timely reporting and follow-up of AEs/SAEs and protocol deviations
• Presenting at Investigator Meetings
• Serving as a study liaison with internal teams and vendors
• Driving patient enrollment and site performance to meet recruitment goals
• Conducting data reviews and supporting Risk-Based Monitoring activities
• Serving as the primary site contact and ensuring proper handling of investigational products and other study supplies
• Serving as a study liaison with internal teams and vendors
• Supporting the execution of study committee meetings (e.g., DMC, CEC, publication)
• Providing support for technical documentation (e.g., PMS, PMCF, CER, CEP), as needed

Qualifications

• Bachelor’s degree in life sciences, medicine, or a similar discipline
• Minimum of 6 to 8 years of industry experience in clinical research or equivalent experience gained with a CRO, pharmaceutical or medical device company
• Experience contributing to cross-functional new product development teams throughout the development lifecycle with demonstrated experience generating clinical evidence strategies
• 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

Preferred Qualifications

• Experience with interventional urology, urology, maternal and child health, or gastroenterology medical devices
• Experience with global clinical projects
• AACR or SOCRA certification

Benefits

• Paid time off and paid volunteer time
• Medical, Dental, Vision
• Pension Plan
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Company Culture

We believe in creating a supportive and inclusive environment where our employees can thrive. Our mission is to operate as a world-class specialist medical company, making and advancing technologies that preserve and restore human dignity. We do this by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.