Senior Clinical Research Associate, Field Monitor

Immunitybio - San Diego, CA

Full-time - Mid Level

San Diego, 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 to combat cancer and infectious diseases. 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 CRA will conduct remote monitoring tasks and provide mentorship and training to newly hired research staff, fostering a collaborative and knowledgeable team environment. This position requires a proactive approach to problem-solving and the ability to communicate effectively with both field and in-house CRAs. The Senior CRA will also be involved in training vendors, investigators, and study coordinators on study requirements, ensuring that all parties are aligned and informed throughout the clinical trial process. Overall, the Senior CRA will contribute significantly to the success of clinical trials, helping to advance ImmunityBio's mission of transforming cancer treatment through innovative therapies.

Responsibilities

• Develop, review and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals.
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
• Communicate scientific rationale for assigned studies to team members and clinical sites.
• Serve as Subject Matter Expert for clinical sites including 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, work with sites to resolve data queries as needed.
• 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) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions.
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues.
• 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, Adobe.
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Strong organizational and multi-tasking skills.
• Knowledge of drug development process.
• Computer literacy: EDC, eTMF, CTMS, etc.
• Working knowledge of ICH E6, and the Code of Federal Regulations.

Nice-to-haves

• Outgoing and confident demeanor.
• Independent thinker and persuasive communicator.
• Detail oriented, with solid organization and time management skills.
• Completes projects with reliability and minimal guidance.

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 and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Unlimited PTO for Exempt Employees
• 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day for Non-Exempt Employees