Clinical Research Associate

PROCEPT BioRobotics • San Jose, CA

1d

About The Position

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH and prostate cancer are treated? Join us as a Clinical Research Associate, where you will play a key role in supporting clinical trials from start to finish. You will assist in developing protocols, case report forms, and consent documents while ensuring compliance with good clinical practices. Your responsibilities will also include site selection, investigator engagement, and study monitoring. This role offers opportunities for growth, including exposure to Regulatory Affairs.

Requirements

• Bachelor's degree in a scientific or health care discipline preferred and /or training; or equivalent combination of education and experience.
• 2+ years' recent experience in clinical role
• Excellent verbal and written communication skills
• Excellent organizational skills along with strong attention to detail
• Ability to work both independently and collaboratively with cross-functional teams
• Highly proficient with Microsoft Office Suite
• Ability to travel approximately 35-40%

Responsibilities

• Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
• Assist in implementing clinical research projects
• Review case report forms and informed consent forms against the study protocol and other governing documents to allow for accurate and thorough data collection to support the product through the regulatory approval process
• Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements
• Organize data in systematic manner to allow for efficient and accurate clinical reports.
• Perform joint site visits with other CRAs to ensure regulatory and study requirements are being fulfilled

Benefits

• full medical coverage
• wellness programs
• on-site gym
• a 401(k) plan with employer match
• short-term and long-term disability coverage
• basic life insurance
• wellbeing benefits
• flexible or paid time off
• paid parental leave
• paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level