Senior CRA - FSP - Medical Device - US Central/West Coast

Job Title: Senior CRA - FSP - Medical Device - US Central/West Coast Job Location: Remote, Montana, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.

You will manage procedures and guidelines from different sponsors and/or monitoring environments (i. e. , FSO, FSP, Government, etc.)

Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.

You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You’ll Do: Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks.

Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing st