Clinical Research Associate
$90,000–$130,000 year
Remote · Aliso Viejo, California, United States
Job Summary
Clinical Research Associate will join our Clinical Operations team in a hands-on role supporting the planning, execution, and monitoring of clinical trials. The CRA will conduct site monitoring visits (initiation, routine, and close-out), build relationships with investigators and site staff, ensure studies comply with the protocol, GCP, and regulatory requirements, and assist in the preparation and review of essential trial documents (informed consent forms, case report forms, investigator brochures). Responsibilities include coordinating with site staff for documentation and data entry, identifying and training investigative sites, maintaining study files per GCP and SOPs, monitoring study progress, reporting findings to the Clinical Study Manager, supporting regulatory submissions, and collaborating with Regulatory Affairs, QA, and Project Management to achieve study objectives. Requires a Bachelor’s degree and at least 4 years of clinical affairs experience, strong communication skills, proficiency with EDC, and willingness to travel up to 50-75% domestically.
Required Qualifications
- Bachelor's degree in life sciences, nursing, or a related field
- Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry
- Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices
- Strong organizational and problem-solving skills
- Excellent communication and interpersonal skills
- Proficiency in Microsoft Office and electronic data capture (EDC) systems
- Ability to travel up to 50-75% domestically
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