Clinical Research Associate II, Field Monitor

Immunitybio - Mariposa, CA

Full-time - Mid Level

Mariposa, 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. The Clinical Research Associate II will interpret the medical and scientific intent of assigned study protocols, assess logistics, risks to research subjects, and safety, as well as data evaluation methods. Communication of the scientific rationale for assigned studies to team members and clinical sites is essential, as is serving as a Subject Matter Expert for clinical sites, providing guidance on protocol interpretation and eligibility requirements. In addition to these responsibilities, the Clinical Research Associate II will oversee the collection of essential documents during study start-up, determine the materials and resources needed for conducting clinical trials, and manage their acquisition and distribution. The role also includes collecting study and site metrics, conducting case report form (CRF) data reviews, and working with sites to resolve data queries. Regular communication with field Clinical Research Associates (CRAs) is necessary to provide information before and after site visits, and the Clinical Research Associate II will partner with field CRAs and Clinical Trial Assistants (CTAs) to address issues identified during site visits. The position requires training vendors, investigators, and study coordinators on study requirements, conducting clinical specimen log reviews, and coordinating the shipment of specimens. The Clinical Research Associate II will also conduct remote monitoring tasks, provide data listings, and compile clinical study report documents to support medical writing activities. This role is integral to the success of clinical trials and requires a detail-oriented individual who can work independently and collaboratively within a team.

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.
• 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, 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.

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
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day