Field Clinical Research Associate
NAMSA
Google Cloud Platform
Clinical Research Associate II, Field Monitor
ImmunityBio, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $112,800 - $124,000 per year
Job Level
JuniorMid-Level
About the role
- Participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies
- 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
- Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
- Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
- Partner with field CRAs and CTAs to resolve issues identified during site visits
- Train vendors, investigators, and study coordinators on study requirements
- Conduct remote monitoring tasks including reconciliation of site investigational product accountability
- Provide data listings and compile clinical study report documents to support medical writing activities
- Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
Requirements
- Bachelor’s degree in a clinical research, science, or health-related field with 4 years of experience in a clinical research setting; or a high school diploma with 6 years of experience in a clinical research setting required
- Minimum of 2 years’ experience as a Clinical Research Associate I required
- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
- Strong organizational and multi-tasking skills
- Ability to set priorities and independent decision making
- Ability to work independently as well as in teams
- Strong oral and written communication skills
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchdata evaluation methodscase report form (CRF) data reviewprotocol interpretationsite feasibility questionnairesinvestigational product accountabilitymedical writingstudy-related training materialsstudy protocolseligibility requirements
Soft skills
organizational skillsmulti-tasking skillsindependent decision makingteamworkoral communication skillswritten communication skillsprioritizationguidancetrainingproblem-solving
