Job Description:
• Perform site management and monitoring activities, including site qualification, initiation, interim monitoring, and close-out visits
• Participate in clinical trials from development and planning through study closure
• Ensure assigned clinical trial sites comply with study protocols, applicable regulations, ICH/GCP, and company or sponsor SOPs
• Review source documentation and clinical data for accuracy, completeness, and consistency
• Monitor participant safety, informed consent processes, investigational product accountability, and protocol compliance
• Identify, document, escalate, and support resolution of issues, including protocol deviations and data queries
• Maintain key performance metrics according to company standards, project requirements, and timelines
• Prepare monitoring reports and required study documentation accurately and on time
• Collaborate with Clinical Team Leads, Project Managers, sponsors, investigators, site personnel, and cross-functional teams
• Build and maintain relationships with clinical research sites and study stakeholders
• Complete administrative activities, including expense and time reporting
• Provide mentoring, guidance, and subject matter support to less experienced team members when appropriate
• Perform other assigned duties
Requirements:
• Degree in life sciences, nursing, pharmacy, or a related field; equivalent education and clinical research experience may be considered
• Previous experience in clinical research, clinical operations, healthcare, or a related field is preferred; experience requirements vary by level
• Experienced CRA candidates require previous independent monitoring experience and ability to perform applicable site visit types
• Working knowledge of Good Clinical Practice (GCP), clinical trial regulations, and research ethics
• Understanding of medical terminology, human physiology, and clinical trial processes
• Strong written, verbal, and presentation skills
• Proficiency with information technology and clinical trial systems
• Excellent customer service, communication, and relationship-building skills
• Flexibility, adaptability, and attention to detail
• Ability to work effectively in a team environment and independently as needed
• Organizational and time management skills, with ability to prioritize tasks and meet project timelines
• Ability to travel nationally and internationally as required
• Ideally based on the West Coast or within reasonable access to West Coast clinical trial sites
Benefits:
• 99% employer-paid health insurance
• 100% employer-paid dental and vision insurance
• 100% employer-paid short-term and long-term disability
• Life insurance policy
• 401(k) retirement plan with 3% employer contribution
• Flexible and hybrid work options
• Unlimited PTO for salaried staff
• 12 corporate holidays
• Employee Assistance Program (EAP)
• Wellness program
• Learning & Development stipend that increases with tenure
• Charitable Match Program
• Wednesdays catered lunches (in-office)