Clinical Research Associate (CRA) III
New
C
CVRxMedical Devices
This position is mostly remote. Please note that our ideal candidates will reside near our headquarters in Brooklyn Park, MNFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 5 years’ experience directly supporting clinical research of an implantable medical device or similar experience in a medical/scientific area; Minimum of 2 years’ experience in monitoring clinical trial sites
- Required Skills
- GCP
Requirements
- Bachelor’s degree.
- Minimum 5 years of experience directly supporting clinical research of an implantable medical device or similar.
- Minimum 2 years of experience monitoring clinical trial sites.
- Deep knowledge of Good Clinical Practices (GCP) and regulatory compliance guidelines.
- Effective comprehension of medical terminology.
- Ability to travel up to 40% within the US by car and air.
- Valid government ID for domestic air travel.
- Valid driver's license and reliable transportation.
- Professional home-office environment with high-speed internet.
Responsibilities
- Develop and maintain successful working relationships with study sites as the primary point of contact.
- Conduct monitoring visits to ensure compliance with study protocol, GCP, and regulatory requirements.
- Collect and track required regulatory documents and perform source data verification.
- Support site IRB submissions, AE/SAE identification, and device accountability processes.
- Prepare high-quality monitoring reports and analyze site performance metrics.
- Review clinical data, oversee corrections, and manage site-level Trial Master File documentation.
- Collaborate with internal teams including Data Management, Safety, Regulatory, and Quality.
- Provide operational input on protocol development, risk assessments, and monitoring plans.
View Full Description & ApplyYou'll be redirected to the employer's site
