Clinical Research Associate

Role overview

The Clinical Research Associate will manage the day-to-day operational execution of clinical trials at investigational sites. The position focuses on protecting data quality, ensuring compliance with regulatory and ethics requirements, and applying Good Clinical Practice standards. You will support several studies across different therapeutic areas, monitor site performance, address operational challenges, and keep communication flowing between sponsor teams and site staff.

Key responsibilities

• Assess site staffing and resourcing needs for site qualification visits, site initiation visits, monitoring visits, and ongoing study support.
• Handle multiple studies at the same time across several trial locations and indications.
• Build, update, and follow a monitoring plan for each assigned trial.
• Coordinate with external investigators, clinic teams, and hospital staff from study start through close-out so monitoring and study activities stay on track.
• Support trial site start-up by confirming that each location has the materials needed to run the study.
• Oversee the site activation process for each study.
• Create and track performance metrics for monitors and sites, investigate concerns, and reduce study risk when issues arise.
• Review study data on a recurring basis to spot inconsistencies or warning signs in collection and monitoring processes.
• Monitor patient enrollment and suggest practical ways for site teams to improve recruitment of eligible participants.
• Help process queries, protocol deviations, adverse events, and related trial documentation.
• Prepare monitoring visit reports.
• Plan and execute site close-out activities when the trial ends.
• Ensure work is aligned with ICH-GCP, SOPs, IRB requirements, study protocols, FDA rules, and other applicable regulatory standards.
• Work with the data management team on study-related activities.
• Draft protocol and informed consent documents for management review.
• Conduct literature reviews for new study indications.
• Support CRF development.
• Assist with investigator meetings.
• Prepare study status tables and presentation decks for leadership review.
• Set up and maintain investigator binders throughout the full study lifecycle.
• Stay current on FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, internal policies, and SOPs.
• Begin assigned duties on time, remain present for the full shift, and attend all scheduled meetings and appointments.
• Be available to work outside standard weekday hours, including weekends if needed, with reasonable advance notice based on business requirements.
• Take on additional tasks as assigned.

Required qualifications

• A bachelor’s degree is required, ideally in Clinical Research, Life Sciences, or a related discipline.
• Relevant clinical experience may be accepted in place of a degree, including experience as a Physician Assistant, Registered Nurse, Emergency Medical Technician, or another healthcare professional role.
• CRA certification such as CCRA or CCRP is strongly preferred.
• About 3 years of relevant experience is preferred, including at least 2 years in industry or experience working with sponsor companies as a clinic coordinator.
• Previous study supervision experience is required.
• A valid Class C driver’s license is required.
• Employment is subject to successful completion of a background check.

Additional information

This is an on-site full-time role based in San Diego, California. The position may require travel and the ability to manage relationships with multiple site teams at once. The role also calls for proficiency with Microsoft Word, Excel, and PowerPoint, strong communication skills, attention to detail, and the ability to work independently as well as in a team-oriented, fast-moving environment.