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 Clinical Trial Associate to help advance the use of CAR T therapy for solid tumors. As part of the clinical team, you will support Affy’s CTM in clinical trial management, including planning, execution, and closeout.
As a Clinical Trial Associate, you will join a small team at a dynamic startup. You 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.
CLINICAL TRIAL ASSOCIATE
Operations Support (70%)
- Assist CTM and CRA, as well as VP of Clinical Operations in day-to-day clinical trial operational activities to ensure study milestones are met in compliance with SOPs and ICH-GCP guidelines.
- Arrange internal and external meetings, prepare agendas and write minutes; ensure they are developed properly and filed in the eTMF.
- Collect and review site regulatory documents for accuracy, completeness, and validity (eg, 1572, CVs, Financial Disclosure documents, licenses, approvals, etc)
- Supports CTM with site feasibility and recruitment, including review of Site Feasibility Questionnaires.
- 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 Clinical Research Organizations (CRO), clinical vendors, clinical sites and key stakeholders.
- Participate in study vendor review, selection, and documentation.
- Maintain study trackers and tools as directed by the CTM.
- Track Forms 1572 and other essential documents; liaise with Regulatory for IND submissions as required.
- Perform other duties as assigned.
Trial Master File Ownership and Oversight (30%)
- Responsible for setting up, maintaining, reviewing, QC and filing trial-related and site-related documents in the eTMF system.
- Oversee TMF to ensure ongoing completeness and accuracy is maintained in a timely basis.
- Main driver of Sponsor oversight for the eTMF system, including CRO oversight for eTMF filing/QC.
- Participate in Inspection Readiness review of eTMF
- Ensure eTMF milestones and data points are completed in a timely manner
- Bachelor’s degree and 1+ year of hands-on clinical research experience at an academic center, CRO, or pharmaceutical/biotech company OR 5+ years of hands-on clinical research experience at an academic center, CRO, or pharmaceutical/biotech company required.
- Fluency in Good Clinical Practice (GCP) and ability to ensure implementation within any clinical study required. Demonstrated ability to adhere to standard operating procedures, 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 experience preferred, but not required.
- Experience with early phase clinical research preferred.
- 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.
- 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.