Senior Clinical Research Associate, Field Monitor

ImmunityBio • El Segundo, CA

1d • Remote

About The Position

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to strengthen the patient's immune system to combat cancer and infectious diseases. The Senior Clinical Research Associate will be an integral part of clinical research teams, ensuring the effective and efficient execution of clinical research studies. This role involves providing training, protocol interpretation, document management, and comprehensive clinical trial support.

Requirements

• Bachelor’s degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting; or a high school diploma with 8 years of experience in a clinical research setting.
• Minimum of 2 years’ experience as a Clinical Research Associate II or higher.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe.
• Excellent written/oral communication skills.
• Strong organizational and multi-tasking skills.
• Understand the job-specific system, processes as defined by the company’s SOPs, and adhere to the requirements listed in those documents.
• Ability to set priorities and independent decision making.
• Ability to work independently as well as in teams.
• Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues.
• 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, and laboratory and pharmacy manuals.
• Interpret the medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, and data evaluation methods.
• Communicate the scientific rationale for assigned studies to team members and clinical sites.
• Serve as a 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 the collection of essential documents during study start-up.
• Collect study and site metrics and maintain study trackers as needed.
• Participate in case report form (CRF) data review and review of source documents, working with sites to resolve data queries.
• Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits.
• Partner with field CRAs 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, training or assisting sites with corrective actions.
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues.
• Review clinical specimen logs and coordinate the shipment of specimens to the sponsor or contracted vendor.
• Conduct remote monitoring tasks, including reconciliation of site investigational product accountability, as needed.
• Provide mentorship and training to newly hired research staff.
• Perform other duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior