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Job: Clinical Trial Assistant, Heat Biologics, Morrisville, NC
Clinical Trial Assistant
Morrisville, NC 27560 United States
Clinical Trial Assistant
Heat Biologics is now recruiting for an opening as a Clinical Trial Assistant (CTA), operating on a permanent basis in the Research Triangle Park, NC. The role includes providing administrative and organizational support to the internal clinical team as well as assigned clinical research sites. The CTA will perform all job functions in accordance with ICH/Good Clinical Practice (GCP) guidelines, federal regulations, and internal Standard Operating Procedures (SOP) and work practices. This position will report to the Clinical Project Manager.
• Serve as internal support for all members of assigned teams.
• Assist investigative sites with completion and submission of all required clinical trial documents prior to site initiation.
• Complete IP Shipment Authorization review checklists.
• Maintain timely and accurate tracking of all clinical trial activity in CTMS.
• Perform reconciliation between CTMS and other systems as requested.
• Support establishment and maintenance of Trial Master File for clinical trials, including Study and Site Level reviews.
• Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) and Institutional Biosafety Committee (IBC) approvals as appropriate.
• Support overall progress of clinical trials by regularly attending clinical trial team meetings, preparing clinical team meeting agendas and minutes, reviewing team communications, and sharing pertinent
information with clinical trial team members and investigative sites as requested.
• Ensure audit/inspection readiness of essential documents at Heat and all investigative sites throughout the duration of clinical trials.
• Manage the procurement of all equipment/supplies provided to investigative sites and ensure appropriate tracking and reporting.
• Maintain positive interactions with internal and external personnel including investigative site staff and vendors as appropriate.
• Execute quarterly Investigator payments based on data of site activities obtained from EDC, IXRS and CTMS tracking.
• Assist with management of third-party vendors, including feasibility, account set-up, invoice review for payment, and troubleshooting.
• Support the successful execution of clinical studies in conformance with ICH/GCP standards, CFR requirements and internal policies and procedures.
Skills and Requirements
• BA/BS degree, life science preferred.
• Minimum 9-12 months experience as CTA at a CRO or Biotech.
• Ability to problem-solve, multi-task and prioritize across tasks.
• Fluent in English (written and verbal).
• Strong communication (written and verbal) and interpersonal skills.
• Proficient in Microsoft Office and Excel.
• Knowledge of ICH GCPs and CFR requirements.
• Ability to report to corporate offices for routine, daily work with minimum to moderate supervision.
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North Carolina Biotechnology Center