Sr. Clinical Research Associate (Pain Trials)

Location: Hybrid in Thousand Oaks, California; candidates should be local to Thousand Oaks or the San Francisco Bay Area. Up to 40% travel may be required.

Company

hirify.global is a biotherapeutics company developing clinical-stage treatments.

What you will do

• Perform site qualification, initiation, interim monitoring, and closeout visits remotely and on site.
• Confirm site readiness, including facilities, staffing, training, essential documents, investigational product processes, laboratories, and system access.
• Review consent documentation, eligibility, safety reporting, investigational product accountability, protocol deviations, and critical trial records.
• Assess site performance, develop action plans, and drive resolution of compliance, recruitment, data-quality, and operational issues.
• Maintain complete and inspection-ready site files and Trial Master File records, including monitoring reports and follow-up documentation.
• Partner with clinical, data, safety, medical, regulatory, supply, quality, CRO, and vendor teams while supporting CRA mentoring and study-level activities.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field, or equivalent education and experience.
• At least 5 years of clinical research experience, including independent site monitoring in pain trials across startup, conduct, and closeout.
• Working knowledge of ICH GCP, FDA regulations, and other clinical-trial requirements.
• Strong ability to evaluate source documentation, identify compliance and data-quality risks, write monitoring reports, and close follow-up actions.
• Experience with CTMS, eTMF, EDC, IRT, and Microsoft Office.
• Ability to independently oversee multiple sites and CRO CRA performance while managing competing study priorities.

Nice to have

• Experience monitoring Phase II or Phase III interventional clinical trials.
• Sponsor or CRO experience, including risk-based monitoring.
• Experience mentoring CRAs, conducting co-monitoring visits, or supporting inspection readiness.

Culture & Benefits

• Hybrid work arrangement with regular on-site and remote monitoring activities.
• Cross-functional collaboration across clinical operations, data management, clinical development, safety, medical, regulatory, supply, and quality.
• Opportunities to contribute to process improvements, lessons learned, and training initiatives.
• Participation in investigator, study team, vendor, and CRO meetings.