Position Summary
Reporting to the Senior Director, Clinical Operations, the Sr. Clinical Research Associate (Sr. CRA) provides hands-on site monitoring and site management for assigned clinical trials from site identification and activation through closeout. The Sr. CRA serves as a primary operational contact for investigative sites, verifies that trial activities are conducted in accordance with the protocol, monitoring plan, applicable regulations, ICH GCP, and company procedures, and drives timely resolution of site-level risks and issues. The role may also support study-level operational activities and provide guidance to less-experienced CRAs.
Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area.
Primary responsibilities include (but are not limited to):
- Perform oversight of site qualification, initiation, interim monitoring, and closeout visits, remotely and on site, in accordance with the monitoring plan and applicable procedures.
- Confirm investigator site readiness, including facilities, staffing, essential documents, training, investigational product processes, laboratory requirements, and required systems access.
- Review informed consent documentation, eligibility, safety reporting, investigational product accountability, protocol deviations, and other critical trial records for compliance and patient protection.
- Assess site performance using enrollment, data quality, query aging, deviation, safety, and visit-timeliness metrics; develop and follow through on site action plans when performance is below expectations.
- Review monitoring visit reports and follow-up letters; protocol deviations, action items, owners, and due dates and track items through closure.
- Identify, document, and escalate significant or persistent site or CRO monitoring issues, including potential serious breaches or noncompliance, and support root-cause analysis and corrective and preventive action planning, as applicable.
- Maintain regular communication with investigators and site staff to reinforce protocol requirements, support recruitment and retention, address operational questions, and promote timely data entry and query resolution.
- Partner with Data Management, Clinical Development, Safety, Medical, Regulatory, Clinical Supply, Quality, and other functions to resolve site-level issues and support coordinated trial execution.
- Ensure site files and Trial Master File records are complete, accurate, current, and inspection ready; reconcile essential documents and follow up on missing or expiring documentation.
- Use clinical trial systems and study platforms, to maintain accurate visit, issue, document, enrollment, and site-status information.
- Support site identification, feasibility, qualification, activation, and closeout activities, including collection and review of essential documents and coordination of site training.
- Contribute to the development and review of study tools and documents, including monitoring plans, site training materials, visit templates, study plans, informed consent forms, eCRFs, and site communications.
- Participate in investigator meetings, study team meetings, and vendor or CRO meetings; provide concise updates on site performance, emerging risks, and recommended actions.
- Provide co-monitoring, peer support, and practical guidance to CRAs or contract monitors and contribute to consistent monitoring practices across the study.
- Support audit and inspection readiness activities, including preparation of site documentation, issue follow-up, and responses to findings within assigned responsibilities.
- Monitor investigator grant and site payment status and support resolution of site budget, invoice, or payment questions in partnership with the appropriate functional owner.
- Contribute to clinical operations process improvements, lessons learned, and training initiatives.
- Up to 40% travel may be required.
Minimum Requirements:
- Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or an equivalent combination of education and relevant experience.
- 5+ years of clinical research experience, including independent clinical site monitoring experience in pain trials across study startup, conduct, and closeout.
- Working knowledge of ICH GCP, applicable FDA regulations, and other regulatory requirements governing clinical trial conduct.
- High level of attention to detail and ability to evaluate source documentation, identify compliance and data-quality risks, write high-quality monitoring reports, and drive follow-up actions to closure.
- Experience working with CTMS, eTMF, EDC, IRT, and Microsoft Office applications.
- Strong written and verbal communication, organization, critical thinking, problem-solving, and stakeholder-management skills.
- Ability to manage oversight of multiple sites and CRO CRA performance independently while managing competing study priorities.
Preferred Qualifications:
- Experience monitoring Phase II or Phase III interventional clinical trials.
- Experience in sponsor and/or CRO environments, including risk-based monitoring approaches.
- Experience providing oversight and mentoring of CRAs, conducting co-monitoring visits, or supporting inspection readiness activities.
