Clinical Research Associate I, Field Monitor

ImmunityBio, Inc.•El Segundo, CA

9d•Remote

About The Position

The Clinical Research Associate I will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.

Requirements

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

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.

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