AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a new member of our Clinical Operations team to help advance the use of CAR T therapy for solid tumors. As part of the clinical team, you will support Affy’s Clinical Trial Manager (CTM) in clinical trial management, including study planning, execution, and closeout.

You will be joining a small team at a dynamic startup and will collaborate within and outside the company to help us advance both our technology and product development. With your curiosity, attention to detail, and enthusiasm, you will leave an indelible mark on Affy. Affy will not accept resumes from recruiters for this role.

Location: Remote (based in East Coast, Central, or Mountain Time Zone)

SENIOR CLINICAL TRIAL (OPERATIONS) ASSOCIATE (ASSOCIATE/JUNIOR CLINICAL TRIAL MANAGER, DOE)

Responsibilities:

Operations Support (60%)

  • Assist CTM and Clinical Operations department in day-to-day clinical trial operational activities to ensure study milestones are met in compliance with SOPs and ICH-GCP guidelines.
  • Support CTM with Study Start-Up: site feasibility, recruitment, and selection, through site initiation visit.
    • Collect essential documents.
    • Request site access from all vendors.
    • Provide Investigator Site File documents to sites.
    • Participate in study vendor review, selection, and documentation.
    • Complete Study-Site Start-Up checklist
  • Support CTM with Study Maintenance
    • Maintain Site Regulatory Trackers via on-going regulatory document reviews.
      • Collect and review site regulatory documents for accuracy, completeness, and validity (e.g., 1572, CVs, Financial Disclosure documents, licenses, approvals, etc.)
      • Provide list of needed regulatory documents to CRA for collection during monitoring visit.
      • Track Forms 1572 and other essential documents; liaise with Regulatory for IND submissions as required.
    • Arrange internal and external meetings (site calls, PI calls, biostats calls, and other study team calls), prepare agendas and write minutes; ensure they are developed properly and filed in the eTMF.
    • Review assigned clinical documents, such as protocol drafts, ICFs, and manuals for clarity and accuracy and following CFR and ICH/GCP guidelines.
    • Develop and maintain strong, collaborative relationships with key trial stakeholders.
    • Support sites via protocol deviation reconciliation and site reminders, FAQs, and daily management.
    • Manage vendors via enrollment reporting, lab supply monitoring, and pending submission reviews.
    • Track and present project activities to sub-team.
    • Maintain study trackers and tools as directed by the CTM.
    • Perform other duties as assigned to keep trial in good standing.
  • Support Study Close-Out
    • Complete regulatory and study reconciliation review, ensuring all site documentation is collected, accurate, current, and complete.
    • Complete Study-Site Close-Out checklist.

Electronic Trial Master File: Veeva Vault Ownership and Oversight (40%)

  • Act as System Administrator of the eTMF.
  • Set up, maintain, review, QC, and file trial- and site- related documents in the eTMF system.
  • Ensure ongoing completeness and accuracy of eTMF is maintained on a timely basis.
  • Oversee the eTMF system, including CRO oversight for eTMF filing/QC and inspection readiness.
  • Ensure eTMF milestones and expected, required documents are completed in a timely manner.
  • Run duplication, inspection readiness, site, milestone, user, and other system generated reports as needed.

Qualifications:

  • Bachelor’s degree and 3+ years of hands-on clinical research experience at an academic center, CRO, or pharmaceutical/biotech company OR 7+ years of hands-on clinical research experience at an academic center, CRO, or pharma/biotech company required. Experience with early phase clinical research preferred.
  • Fluency in Good Clinical Practice (GCP) and ability to ensure implementation within any clinical study required. Demonstrated ability to adhere to standard operating procedures (SOP), GCP, and FDA regulations.
  • Demonstrated knowledge of and experience with regulatory aspects of pharmaceutical development, including inspection readiness.
  • Experience setting up and maintaining an eTMF system. Veeva Vault eTMF experience required.
  • Excellent written and verbal communication skills.
  • Meticulous attention to detail, including capacity to conduct thorough self-reviews.
  • Ability to interact positively with scientific and non-technical peers.
  • Ability to work autonomously with an orientation towards continuous improvement.
  • Highly organized, collaborative, and motivated in a fast-paced startup environment.
  • Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive) and electronic Trial Master Files.

This is a salaried, benefits-eligible position.