Clinical Research Associate

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

📋 Description

• Assist in the recruitment of investigators, selection of sites, as well as study startup and close-out tasks.

• Provide continuous operational support to investigative sites through phone and email communications.

• Collect, review, and monitor essential regulatory documents and Investigator Site Files.

• Maintain the electronic Trial Master File (eTMF).

• Review data and findings within Electronic Data Capture systems.

• Compose, track, and follow up on clinical data queries with site personnel.

• Support traveling Clinical Research Associates (CRAs) through remote monitoring activities.

• Track key performance indicators for sites and update Clinical Trial Management Systems.

• Ensure trial execution adheres to GCP, ICH guidelines, FDA/local regulations, and study-specific SOPs.

• Report site non-compliance and protocol deviations to Clinical Operations Management.

• Conduct qualification, site initiation, interim monitoring, and close-out visits, whether in-person or via remote monitoring tools.

• Review source documents, medical records, and Case Report Forms to confirm data accuracy, completeness, and integrity.

• Identify, document, and track protocol deviations, adverse events, and data queries.

• Collaborate with site investigators to implement corrective and preventive actions.

• Verify accountability, storage, dispensing, and return of investigational products.

• Maintain thorough documentation in the Trial Master File.

• Write comprehensive monitoring visit reports within specified timelines.

• Train investigators and clinical research coordinators on study protocols, EDC systems, and regulatory requirements.

⛳️ Requirements

• Bachelor's or advanced degree in a life science, nursing, pharmacy, or health-related field.

• Over 2 years of experience in clinical research, such as roles as a Clinical Research Coordinator, clinical data assistant, or junior CRA.

• In-depth knowledge of ICH-GCP guidelines, FDA regulations, and EU/local ethics/IRB processes.

• Proficiency in Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote data review tools.

• Excellent attention to detail along with strong problem-solving skills.

• Effective verbal and written communication abilities.

• High levels of organization and time management skills.

• Willingness and ability to travel to designated clinical trial sites or for co-monitoring, with travel up to 30%.

🏝️ Benefits

• Annual bonus.

• Equity.

• Generous benefits package.