FSP Sr. CRA I

Job Title: FSP Sr. CRA I Job Location: Remote, California, 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 Senior Clinical Research Associate 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. DESCRIPTION As a Senior Clinical Research Associate I in our FSP model, you will be dedicated to one specific client, acting as a representative of the client while exercising strong communication and collaboration skills. You will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will act as a site processes specialist, ensuring 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. What You'll Do: Monitors investigator sites with a risk-based monitoring approach. Applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive action