Senior Clinical Research Associate

This is a fully remote position, open to applicants in California.

📋 Description

• Assist study lead(s) with the daily operational management of one or multiple clinical trials, taking responsibility for vendor and/or regional oversight.

• Provide guidance and training to junior Clinical Research Associates (CRAs) and site staff.

• Serve as a primary contact for investigative sites, responding to inquiries and resolving challenges while ensuring compliance with study protocols and regulatory standards.

• Engage proactively in strategies for patient recruitment and enhancements in data quality.

• Perform comprehensive reviews and validations of clinical trial data to ensure accuracy, completeness, and overall quality.

• Oversee and maintain essential trial documentation, such as informed consent forms, regulatory filings, and investigator records.

• Aid in the preparation and submission of regulatory documents, including submissions to Institutional Review Boards.

• Ensure that trials are executed in accordance with Good Clinical Practice (GCP) guidelines and applicable regulations.

⛳️ Requirements

• A Bachelor's degree in a relevant field (Life Sciences, Nursing, etc.) or equivalent experience.

• Over 6 years of experience in clinical operations or related drug development.

• Required experience in vendor/clinical service provider or regional site management.

• Solid understanding of GCP, ICH guidelines, and regulatory standards for clinical research.

• Exceptional organizational and time-management capabilities.

• Strong communication and interpersonal skills.

• Ability to work both independently and collaboratively within a cross-functional team.

• Proficient in Microsoft Office applications, clinical trial management systems, and electronic data capture systems.

• Willingness to travel to investigational sites as necessary.

• Familiarity with early phase clinical trial protocols and procedures is a plus.

• Experience with sponsors is preferred.

🏝️ Benefits

• Comprehensive health coverage.

• Opportunities for professional development and training.

• Flexible work environment.

• Competitive salary and performance-based incentives.