Senior Clinical Research Associate, Field Monitor

Unclassified - El Segundo, CA

Full-time - Mid Level

El Segundo, CA

About the position

The Senior Clinical Research Associate at ImmunityBio, Inc. plays a pivotal 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 such as site initiation training slides, informed consent form templates, and procedures manuals. The Senior Clinical Research Associate will interpret the medical and scientific intent of assigned study protocols, logistics, risks to research subjects, and safety data evaluation methods. Communication of the scientific rationale for assigned studies to team members and clinical sites is also a key function of this role. As a Subject Matter Expert for clinical sites, the Senior Clinical Research Associate will provide guidance on protocol interpretation and eligibility requirements. This includes creating, editing, distributing, and collecting site feasibility questionnaires, overseeing the collection of essential documents during study start-up, and maintaining study trackers. The role also involves participating in case report form (CRF) data review, resolving data queries with sites, and ensuring that sites maintain sufficient investigational product (IP) to conduct trials effectively. Training vendors, investigators, and study coordinators on study requirements is essential, as is conducting remote monitoring tasks and providing mentorship to newly hired research staff. The position requires a Bachelor's degree in a clinical research, science, or health-related field, along with significant experience in a clinical research setting. The ideal candidate will possess strong organizational and communication skills, proficiency in various software applications, and a solid understanding of the drug development process. The role demands the ability to work independently and collaboratively, with a focus on detail and reliability in project completion.

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.
• 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.
• Conduct 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.
• Perform 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.
• Excellent written/oral communication skills as well as 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, provide solutions and guidance to in-house team on how to address issues.
• Strong oral and written communication skills.
• Detail oriented, with solid organization and time management skills.
• Knowledge of drug development process.
• Computer literacy: EDC, eTMF, CTMS, etc.
• Working knowledge of ICH E6, and the Code of Federal Regulations.

Nice-to-haves

• Experience with remote monitoring tasks.
• Familiarity with clinical trial management systems (CTMS).
• Knowledge of regulatory requirements in clinical research.

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