Job Details
Posted 25 June, 2026
Job Id: 628889
Spec 2, Clinical Operations, Clinical Research Associate
Job Description
Onsite role, Irvine, CA, medical device experience preferred
Role Purpose
Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
Essential Job Functions
Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.
Assist with any site remediation activities, as applicable
Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
Required
Bachelor’s Degree or Equivalent Life Sciences or Nursing
3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
Experience with electronic data capture.
Preferred
Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
Pay $45-57/hr based on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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