Clinical Research Associate II, Field Monitor

Immunitybio - San Diego, CA

Full-time - Mid Level

San Diego, CA

Administrative and Support Services

About the position

The Clinical Research Associate II at ImmunityBio will play a crucial role in the clinical research teams, ensuring the effective and efficient conduct of clinical research studies. This position involves a variety of responsibilities, including the development, review, and updating of study-related training materials and documents such as site initiation training slides, informed consent form templates, and procedures manuals. The Clinical Research Associate II will interpret the medical and scientific intent of assigned study protocols, assess logistics, identify risks to research subjects, and evaluate data methods. Communication of the scientific rationale for assigned studies to team members and clinical sites is also a key function of this role. As a Subject Matter Expert for clinical sites, the Clinical Research Associate II will provide guidance on protocol interpretation and eligibility requirements. This includes creating, editing, distributing, and collecting site feasibility questionnaires, overseeing the collection of essential documents during study start-up, and determining the materials and resources needed to conduct the clinical trial. The role also involves collecting study and site metrics, maintaining study trackers, conducting case report form (CRF) data reviews, and resolving data queries with sites. Regular communication with field Clinical Research Associates (CRAs) is essential to provide information before and after site visits, and to partner with them to resolve issues identified during these visits. The Clinical Research Associate II will work closely with the Supply Chain to ensure that sites maintain sufficient investigational product (IP) and will train vendors, investigators, and study coordinators on study requirements. Additionally, this position requires conducting remote monitoring tasks, reviewing clinical specimen logs, and coordinating the shipment of specimens to sponsors or contracted vendors. The Clinical Research Associate II will also support medical writing activities by providing data listings and compiling clinical study report documents, as well as creating and reviewing presentation materials for various stakeholders. Overall, this role is integral to the success of clinical trials and the advancement of ImmunityBio's mission to develop innovative therapies for cancer treatment.

Responsibilities

• Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, and procedures manuals.
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, and safety, data evaluation methods.
• 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.
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
• Collect study and site metrics and maintain study trackers as needed.
• Conduct case report form (CRF) data review and review of source documents, working with sites to resolve data queries.
• Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits.
• Partner with field CRAs and CTAs 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.
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors.
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability.
• Provide data listings and compile clinical study report documents to support medical writing activities.
• Create and/or review slides, overheads, etc., for project, departmental, sponsor, and/or business development presentations.
• Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in a clinical research, science, or health-related field with 4 years of experience in a clinical research setting; or a high school diploma with 6 years of experience in a clinical research setting.
• Minimum of 2 years' experience as a Clinical Research Associate I required.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe.
• Excellent written and oral communication skills.
• Strong organizational and multi-tasking skills.
• Ability to maintain corporate confidentiality at all times.
• Ability to set priorities and make independent decisions.
• Ability to work independently as well as in teams.
• Strong oral and written communication skills with an outgoing and confident demeanor.
• Detail-oriented with solid organization and time management skills.
• Ability to complete projects with reliability and minimal guidance.
• Knowledge of the drug development process.
• Computer literacy in EDC, eTMF, CTMS, etc.
• Working knowledge of ICH E6 and the Code of Federal Regulations.

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) including 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