Clinical Research Associate II, Field Monitor

Immunitybio - El Segundo, CA

Full-time - Mid Level

El Segundo, CA

Administrative and Support Services

About the position

ImmunityBio, Inc. is seeking a Clinical Research Associate II to join our clinical research teams. This role is pivotal in ensuring the effective and efficient conduct of clinical research studies. The Clinical Research Associate II will be responsible for providing training, interpreting protocols, collecting and reviewing documents, and offering overall support for clinical trials. The successful candidate will develop, review, and update study-related training materials and documents, including site initiation training slides, informed consent form templates, and procedures manuals. They will interpret the medical and scientific intent of assigned study protocols, assess logistics, and evaluate risks to research subjects, ensuring safety and compliance throughout the study process. In this position, the Clinical Research Associate II 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 determine the materials and resources needed to conduct the clinical trial. The role also involves maintaining study trackers, conducting case report form (CRF) data reviews, and collaborating with field Clinical Research Associates (CRAs) to resolve data queries and issues identified during site 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. The position requires strong communication skills, as the Clinical Research Associate II will regularly communicate with team members and clinical sites, providing updates and support. They will also conduct remote monitoring tasks, review clinical specimen logs, and coordinate the shipment of specimens to sponsors or contracted vendors. The role demands a detail-oriented individual who can manage multiple tasks effectively and work independently as well as part of a team. This position is remote, with the expectation of travel up to 75% based on study requirements, and offers the flexibility to work across various time zones.

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.
• 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, work 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) 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 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 of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations.
• Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.

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, Adobe.
• Excellent written/oral communication skills.
• Strong organizational and multi-tasking skills.
• Maintain corporate confidentiality at all times.
• Ability to set priorities and independent decision making.
• Ability to work independently as well as in teams.
• Strong oral and written communication skills.
• 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.
• 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

• Experience with clinical trials and data management systems.
• Familiarity with regulatory requirements and compliance in clinical research.

Benefits

• AD&D insurance
• Disability insurance
• Health insurance
• Unlimited paid time off
• Dental insurance
• Flexible spending account
• Paid time off
• Employee assistance program
• Vision insurance
• 401(k) matching
• Employee discount
• Flexible schedule
• Pet insurance