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Clinical Research Associate, In-House Specialist

2 months ago

Mariposa, California, United States ImmunityBio Full time
Job Summary:

The Clinical Trials Associate will play a critical role in ensuring the effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review, and overall clinical trial support.

Key Responsibilities:
  • Develop, review, and update study-related training materials and documents, including site initiation training slides, informed consent form templates, and procedures 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, 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.
  • Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
  • Collect study and site metrics and maintain study trackers, as needed.
  • 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.
  • 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.
  • Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor.
  • Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors.
  • Conduct remote monitoring tasks, including reconciliation of site investigational product accountability.
  • Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission.
  • Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed.
  • 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.
  • Participate in clinical operations safety reporting activities, including distribution to sites, tracking, IRB submission, and filing.
  • Compile and prepare clinical trial information for IRB reporting and submission.
  • Prepare and deliver reports and presentations to Senior Management on study metrics and clinical trial status.
  • Collaborate with other functional groups, such as data management, pharmacovigilance, biostatistics, etc., to ensure clinical trial activities are conducted efficiently, compliant with regulations and standards, and aligned with project objectives.
  • Assist Clinical Trial Manager (CTM) with management of trial aspects as delegated by the CTM.
Requirements:
  • Bachelor's degree with 4+ years of experience as a Clinical Trials Associate, or Associate's degree with 7+ years of experience as a Clinical Trials Associate, or 10+ years of clinical research experience.
Preferred Qualifications:
  • Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe.
  • Excellent written and oral communication skills.
  • Strong organizational and multi-tasking skills.
  • Maintain corporate confidentiality at all times.
  • Ability to set priorities and make independent decisions.
  • Ability to work independently as well as in teams.
  • 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:
  • This position works on-site.