IB Temporary – Senior CRA, Field Monitor
ImmunityBio, Inc. · California, United States
- Hybrid
- Full-time
- $65,380 / year
- California, United States
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Job highlights
- Monitor clinical research studies effectively and efficiently.
- Interpret protocols, provide training, and collect documents.
- Support clinical sites and resolve data queries.
- Manage investigational product and specimen shipments.
- Mentor new research staff and ensure compliance.
About the role
Position Summary
IB Temporary - Senior CRA, Field Monitor 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.Essential Functions
- 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 investigational product accountability, as needed
- Provide mentorship and training to newly hired research staff.
- Performs other duties as assigned.
Education & Experience
- Bachelor’s degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting required; or
- High school diploma with 8 years of experience in a clinical research setting required
- Minimum of 2 years’ experience as a Clinical Research Associate II or higher required
Knowledge, Skills, & Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
- Excellent written/oral communication skills as well as strong organizational and multi-tasking 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. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
- Maintain corporate confidentiality at all times
- 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
Working Environment / Physical Environment
- Must be able to travel up to 75% of the time based on study requirements
- Remote with ability to work flexible hours for various time zones
Compensation
The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.- National Market (all markets unless identified as Premium): $61.54 (entry-level qualifications) to $65.38 (highly experienced) per hour
- Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $63.94 (entry-level qualifications) to $67.31 (highly experienced) per hour
Benefits
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include:- 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
Equal Opportunity Employer Statement
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.Key skills/competency
Senior Clinical Research Associate, Field Monitor, Clinical Trials, Protocol Interpretation, Document Review, Site Initiation, Training, Data Queries, Investigational Product, ICH E6, CFR, Drug Development, Clinical Research Setting, CRA II or higher.Skills & topics
- Senior Clinical Research Associate
- Field Monitor
- Clinical Trials
- Biotechnology
- Immunotherapy
- Drug Development
- Clinical Research
- CRA
- ICH E6
- CFR
- Remote
- Field Monitoring
- Protocol Interpretation
- Site Support
- Mentorship
How to get hired
- Tailor your resume: Highlight your clinical research experience, focusing on your CRA II or higher experience and any specific therapeutic areas mentioned in the job description. Quantify your achievements whenever possible.
- Craft a compelling cover letter: Emphasize your understanding of clinical trial processes, protocol interpretation skills, and experience with training and mentorship. Clearly state why you are a strong fit for the Senior CRA Field Monitor role at ImmunityBio.
- Prepare for interviews: Be ready to discuss your experience with ICH E6, CFR, drug development, and specific clinical trial systems (EDC, eTMF, CTMS). Prepare examples demonstrating your problem-solving abilities and leadership potential.
- Showcase your remote work readiness: Highlight your ability to work independently, manage your time effectively, and communicate across different time zones, given the remote nature of the role.
- Research ImmunityBio: Understand their mission, pipeline, and recent news. Demonstrating this knowledge will show your genuine interest in contributing to their goal of conquering cancer.
Technical preparation
Master EDC, eTMF, and CTMS systems.,Study ICH E6 and CFR regulations.,Practice protocol interpretation skills.,Prepare for site initiation training delivery.
Behavioral questions
Describe a complex site issue you resolved.,How do you mentor junior research staff?,Give an example of managing priorities independently.,How do you ensure site compliance remotely?
Frequently asked questions
- What is the typical career progression for a Senior CRA Field Monitor at ImmunityBio?
- While this is a temporary position, successful Senior CRA Field Monitors at ImmunityBio often gain valuable experience in clinical trial management and cross-functional collaboration. This experience can lead to opportunities in other areas of clinical operations, project management, or leadership roles within the company or the broader biopharmaceutical industry.
- What specific therapeutic areas does ImmunityBio focus on, and is experience in those areas preferred for the Senior CRA Field Monitor role?
- ImmunityBio focuses on developing cell and immunotherapy products for cancer and infectious diseases. While specific therapeutic area experience is not explicitly stated as a mandatory requirement, a strong understanding of oncology or immunology would be highly beneficial and can be highlighted in your application for the Senior CRA Field Monitor position.
- What are the expectations for travel as a Senior CRA Field Monitor at ImmunityBio?
- The role requires travel up to 75% of the time, as dictated by study requirements. This travel will likely involve visiting clinical sites to ensure effective and efficient conduct of research studies, including training, protocol interpretation, and document review.
- What are the primary responsibilities of a Senior CRA Field Monitor at ImmunityBio beyond site monitoring?
- Beyond traditional site monitoring, the Senior CRA Field Monitor is expected to develop training materials, interpret scientific intent of protocols, serve as a Subject Matter Expert for clinical sites, oversee document collection, participate in data review, and provide mentorship to new research staff. They also collaborate with internal teams and external vendors.
- How does ImmunityBio support the professional development of its clinical research staff?
- ImmunityBio emphasizes professional development opportunities for its growing team. This includes the ability to work across different areas of the company and access to a collaborative team environment, which can foster learning and skill enhancement for roles like the Senior CRA Field Monitor.
- What are the key systems and software a Senior CRA Field Monitor at ImmunityBio will use?
- A Senior CRA Field Monitor at ImmunityBio should be proficient in standard office software (MS Word, Excel, PowerPoint, Outlook, Adobe) and have computer literacy in clinical trial systems such as EDC (Electronic Data Capture), eTMF (electronic Trial Master File), and CTMS (Clinical Trial Management System).