Senior Clinical Research Associate
About The Position
The Senior Clinical Research Associate is responsible for monitoring and site management activities to ensure timelines and deliverables are met at assigned sites. Proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. Engages with study investigators, vendors, and internal/external stakeholders as a member of the Clinical Research Team. Build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP, ISO14155, and Laborie SOPs. Focus on subjects’ rights, safety, and well-being and to ensure 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
- Responsible for comprehensive site management across all phases of clinical trials in compliance with Laborie SOPs, ICH-GCP, and local regulations.
- 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.
- Serves 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
251-500 employees
