Note: The job is a remote job and is open to candidates in USA. ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative cell and immunotherapy products to enhance the human immune system's ability to combat cancer. The Senior Clinical Research Associate will support clinical research teams by ensuring effective study conduct through training, protocol interpretation, and overall clinical trial support.
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 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
Skills
- Bachelor's degree in a clinical research, science, or health-related field with 6 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required
- Minimum 4 years of on-site monitoring experience required
- 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
- 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
Benefits
- Discretionary bonus
- Equity award
- 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
- Tools and resources you need to optimize your Health and Wellness
Company Overview