Senior Clinical Research Associate, Field Monitor

Immunitybio - Mariposa, CA

Full-time - Senior

Mariposa, CA

Administrative and Support Services

About the position

The Senior Clinical Research Associate (CRA) at ImmunityBio will play a pivotal role in the execution of clinical research studies aimed at developing innovative therapies for cancer treatment. This position involves collaborating with clinical research teams to ensure that studies are conducted efficiently and effectively. The CRA will be responsible for developing, reviewing, and updating training materials and study-related documents, including site initiation training slides and informed consent forms. They will interpret the medical and scientific intent of study protocols, assess logistics, and evaluate risks to research subjects, ensuring that all safety measures are adhered to throughout the study process. In addition to document management, the Senior CRA will serve as a Subject Matter Expert for clinical sites, providing guidance on protocol interpretation and eligibility requirements. They will oversee the collection of essential documents during study start-up and maintain study trackers to monitor progress. The role also includes participating in data review, resolving data queries with clinical sites, and ensuring that investigational products are adequately supplied and monitored. The Senior CRA will communicate regularly with both field and in-house CRAs, providing updates and resolving issues identified during site visits. They will also be responsible for training vendors, investigators, and study coordinators on study requirements, as well as conducting remote monitoring tasks as needed. Mentorship and training of newly hired research staff will also be a key component of this role, ensuring that the team is well-equipped to meet the demands of clinical research.

Responsibilities

• Develop, review and update study-related training materials and documents including site initiation training slides and informed consent form templates.
• Interpret medical and scientific intent of assigned study protocols and study procedures, including logistics and risks to research subjects.
• Communicate scientific rationale for assigned studies to team members and clinical sites.
• Serve as Subject Matter Expert for clinical sites, providing guidance on protocol interpretation and eligibility requirements.
• Create/edit, distribute and collect site feasibility questionnaires.
• Oversee and support collection of essential documents during study start-up.
• Collect study and site metrics and maintain study trackers as needed.
• Participate in case report form (CRF) data review and review of source documents, working with sites to resolve data queries.
• Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits.
• Partner with field CRAs to resolve issues identified during site visits.
• Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) and resolve IP temperature monitoring excursions.
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues.
• Conduct clinical specimen log review and coordinate shipment of specimens to the sponsor or contracted vendor.
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability as needed.
• Provide mentorship and training to newly hired research staff.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting; or a high school diploma with 8 years of experience in a clinical research setting.
• Minimum of 2 years' experience as a Clinical Research Associate II or higher required.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe.
• Excellent written and oral communication skills, along with strong organizational and multi-tasking skills.
• Knowledge of drug development process and working knowledge of ICH E6 and the Code of Federal Regulations.
• Ability to set priorities and make independent decisions.

Nice-to-haves

• Experience with electronic data capture (EDC), electronic trial master file (eTMF), and clinical trial management systems (CTMS).
• Outgoing and confident demeanor with strong persuasive communication skills.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance
• Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) including 11 Holidays, Unlimited PTO for Exempt Employees, and various vacation and personal days for Non-Exempt Employees.