Clinical Research Associate, In-House

Role Overview

• Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
• Track and maintain ImmunityBio study personnel list and training records for assigned studies
• Communicate study rationale for assigned studies to study team members and clinical sites
• Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
• Create/edit site feasibility questionnaire template, track feasibility/start-up activities
• Create regulatory document templates, oversee and support collection of essential documents during site start-up
• Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
• File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
• Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
• Partner with field CRAs and CTAs to resolve document issues identified during site visits
• Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
• File documents to the TMF and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
• File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
• Perform content review and post approval review of documents filed to the TMF
• Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
• Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers, create and manage site shipping accounts
• Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
• 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, perform invoice reconciliation at site close-out
• Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations and functional groups as needed. Request invoice approval from internal supplier designee(s).
• Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
• 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, TMF filing and completion of required form for updates to Safety Distribution System for site personnel or site status changes
• Submit clinical trial documentation to central IRB after initial submission by the CTM as needed
• Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are documented efficiently, compliant with regulations and standards, and aligned with project objectives
• Assist CTM with management of trial projects as delegated by the CTM
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Requirements

• Bachelor’s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years’ clinical research experience) required;
• Associate’s degree with 7+ years’ experience as a Clinical Trials Associate (or 10+ years clinical research experience) required
• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
• Excellent written/oral communication skills
• Strong organizational and multi-tasking skills
• Maintain corporate confidentiality at all times
• Ability to set priorities and independent decision making
• 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

Tech Stack

• ERP

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
• Discretionary bonus and equity award