Clinical Trial Assistant

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

POSITION SUMMARY

ImmunityBio, Inc. is developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.

Responsible for assisting the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.

ESSENTIAL FUNCTIONS

• Provide general administrative support to the Clinical Operations Department and assistance to Clinical Trial Manager (CTM) and Project Director
• To assist the Clinical Operations teams in the completion of all required tasks to meet departmental and project goals
• Basic knowledge of ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems
• Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival
• Review, file and track study documents collected by the field Clinical Research Associate (CRA), provide document review assistance as needed
• Manage ordering/dispatch and tracking of trial materials (e.g. binders, notebooks, lab supplies) as appropriate
• Review Investigator/Site invoices for accuracy and reconcile against the case report forms (CRFs) and budget for payment submission
• Assist with central IRB submissions, track IRB submissions and approval
• Assist with the collection of required documents during site start-
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
• Route study documents to the appropriate personnel for validated digital signature
• Distribute, file and track safety reports as delegated by the Clinical Trial Manager (CTM)
• Provide support to the Project Manager and project team with Investigator Meeting coordination, agenda preparation and generate meeting minute
• Provide support to the clinical team, as needed

EDUCATION/EXPERIENCE REQUIREMENTS

• BA/BS degree with 0-2 years of clinical research experience (or 5 years of clinical research experience without BA/BS)
• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• 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.
• Strong oral and written communication skills
• Detail oriented, with solid organization and time management skills
• Working knowledge of good documentation practices (GDP)
  

• All hires are based upon successful completion and passage of a background check.