Clinical Trial Associate (or Senior CTA)

Cellphire Therapeutics, Inc.

Rockville, MDFull-timePosted Apr 23, 2026

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Qualifications

  • •Bachelor's degree, preferably in a scientific or public health discipline
  • •1–2 years of experience within a clinical profession or biotech-oriented company
  • •Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and MS Project/Smartsheet
  • •Basic understanding of FDA regulations, ICH-GCP guidelines, other applicable regulatory requirements, and the biologics development process
  • •Strong analytical and problem-solving skills with meticulous attention to detail
  • •Excellent written and verbal communication skills
  • •Demonstrated ability to multi-task and work independently in a fast-paced, flexible environment
  • •4 more items(s)

Responsibilities

  • •The role involves tracking timelines, managing vendor deliverables, overseeing clinical trial documentation, and facilitating communication among stakeholders
  • •Assist the Study Manager and team in developing and maintaining integrated study timelines (MS Project or equivalent), identifying potential risks to milestones
  • •Monitor CRO and vendor deliverables against contractual timelines and Key Performance Indicators (KPIs)
  • •Lead the planning and execution of internal/external project meetings, including the development of agendas and strategic meeting minutes
  • •Identify gaps in current clinical workstreams and support the development of departmental SOPs and study-specific tools and training to increase efficiency
  • •Documents and escalates clinical trial risks and issues and drives timely follow through and completion
  • •Assist in tracking study expenditure and processing vendor invoices against the approved budget and work orders
  • •Facilitate the routing and execution of Clinical Trial Agreements (CTAs), Master Service Agreements (MSAs), and Statements of Work (SOWs)
  • •Manage the site payment tracker, ensuring investigators are paid accurately based on completed enrollment and monitoring report data
  • •Organize, maintain, and archive sponsor-required clinical trial documents (CRFs and essential documents) per ICH/GCP guidelines within the Trial Master File (TMF); Conduct periodic reconciliations between the CRO eTMF and the Sponsor TMF to ensure all essential documents are present and contemporaneously filed; Assist the Sr
  • •CRA in verifying that site-level Investigator Site Files (ISF) are being maintained by the CRO in accordance with the site’s specific GCP requirements; Perform quality control (QC) checks on documents uploaded by the CRO to ensure legibility and correct indexing
  • •Assist in tracking and reporting study site and overall program progress, ensuring timely review of site reports and data entries
  • •Maintain real-time tracking of patient recruitment, enrollment status, and manufacturing schedules for clinical studies
  • •Facilitate streamlined communication between the CRO, medical monitor, regulatory consultants, and clinical sites
  • •Participate in the development and review of core study documents, including protocols, Informed Consent Forms (ICFs), and Investigational Brochure (IB)
  • •Coordinate with manufacturing or CMOs to ensure adequate investigational drug supplies are available and maintained at sites based on enrollment demands
  • •Facilitate the reconciliation of Investigational Product (IP) records to ensure compliance with GCP requirements for product handling and disposal
  • •Assist logistics department with the shipment and tracking of IP and associated supplies
  • •Access EDC database and CRO data systems/platforms to generate, export, and organize data for monitoring and review by Clinical Operations leadership
  • •Support with document maintenance and the preparation of documents for IRB and OHRO submissions
  • •17 more items(s)
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