Clinical Research Associate

Role overview

This position supports Medical Affairs work tied to expanded access initiatives, out-of-specification case handling, and single-patient IND activities. The role focuses on the hands-on coordination of treatment-use and clinical support operations, including tracking deliverables, partnering with vendors and outside organizations, maintaining communication with sites and investigators, and monitoring progress, risks, and compliance against relevant regulations, internal SOPs, and program-specific requirements.

Core responsibilities

• Review study and start-up documents as assigned, such as protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, CRFs, CRF completion instructions, and related charters or plans.
• Support execution of clinical studies and expanded access programs by owning assigned workstreams and contributing as an active study team member.
• Coordinate timelines, documentation, communications, and follow-up for out-of-specification cases, expanded access programs, and single-patient IND requests.
• Work with vendors, CROs, and external partners to communicate schedules, oversee transferred responsibilities, and confirm delivery against expectations; provide corrective guidance when needed.
• Participate in internal meetings and other required forums to aid planning, issue management, and execution.
• Deliver training support at investigator meetings and other program meetings such as site initiation visits and monthly teleconferences when required.
• Prepare and assess site feasibility materials needed for participation, where applicable.
• Track major deliverables including screening, enrollment, data movement, protocol deviations, and other program milestones.
• Spot emerging operational risks or issues early, recommend actions, implement solutions where appropriate, and escalate to senior leadership when necessary.
• Compile metrics and status reports for management review.
• Help resolve clinical trial queries related to interim analysis, primary analysis, and final database lock activities, as applicable.
• Draft site newsletters and other study or program communications covering best practices, lessons learned, and frequently asked questions, in partnership with the study team.
• Respond to routine questions from sites and external stakeholders while following ICH GCP, protocol requirements, and treatment-use rules.
• Contribute to special projects and additional tasks as assigned.
• Use correct medical and scientific terminology in documentation, communication, and day-to-day operational support.

Qualifications and experience

• BS/BA/RN in nursing, science, or another health-related discipline, along with 3 to 5 years of relevant experience.
• Experience in oncology or hematology is preferred.
• Cellular therapy background is an added advantage.
• Prior use of iMedidata or RAVE EDC is beneficial.
• Study start-up exposure from a site regulatory, CRO, or sponsor role is a plus.
• Ability to handle competing deadlines, incomplete information, and unplanned changes.
• Strong analytical thinking and problem-solving capability.
• Very high attention to detail.
• Excellent organization, prioritization, and multitasking skills.
• Strong interpersonal, verbal, and written communication abilities in a collaborative setting.
• Comfort in a fast-moving small-company environment with limited direction and shifting priorities.
• Working knowledge of transplant patient care and apheresis collection is advantageous.

Additional information

This position is based in Santa Monica, California and is onsite. It is a contract role. The posting does not specify salary, stipend, number of openings, start date, or application deadline.