Spec 2, Clinical Operations, Clinical Research ...

Job DescriptionOnsite role, Irvine, CA, medical device experience preferredRole 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 experienceEqual 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.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.

Created: 2026-04-15