Senior Clinical Research Associate, Field Monitor

🕒 2 days ago

🏄 California – Remote

🏄 California – Remote

💵 $128k - $136k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

📋 Description

• 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 • Collect study and site metrics and maintain study trackers, as needed • Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed • 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) 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 • Clinical specimen log review, coordinating 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. • Performs other duties as assigned.

🎯 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 required • Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe • 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. • 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