Clinical Research Associate I, Field Monitor
ImmunityBio, Inc.
Senior Clinical Research Associate, Field Monitor
ImmunityBio, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $128,000 - $140,000 per year
Job Level
Senior
About the role
- Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
- 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
- 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) and 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 and coordinating shipment of specimens to the sponsor or contracted vendor
- Conduct remote monitoring tasks including reconciliation of site investigational product accountability
- 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
- 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
- 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
- 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
- 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
