Clinical Research Associate I, Field Monitor jobs in United States
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ImmunityBio, Inc. · 16 hours ago

Clinical Research Associate I, Field Monitor

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative therapies to enhance the human immune system in the fight against cancer. The Clinical Research Associate I will support clinical research teams by ensuring efficient conduct of studies, providing training, and managing documentation and communications with clinical sites.

Health CareHealth DiagnosticsTherapeutics

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
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Qualification

Clinical research experienceDrug developmentEDC/eTMF/CTMSMS WordExcelPowerPointICH E6 knowledgeIndependent decision makingCommunication skillsOrganizational skillsDetail orientedTeamwork ability

Required

Bachelor's degree in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting 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
Must be able to travel up to 75% of the time based on study requirement

Preferred

2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred

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

Company

ImmunityBio, Inc.

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ImmunityBio, Inc.

Funding

Current Stage
Public Company
Total Funding
$1.36B
Key Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M

Leadership Team

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Enrique Diloné
Chief Technology Officer
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Leonard Sender
COO
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Company data provided by crunchbase