Senior Clinical Research Associate
Company: Diakonos Oncology
- Location: United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
We’re hiring: Senior Clinical Research Associate (Remote, US) 🧬
At Diakonos Oncology, we’re developing DOC1021, a dendritic cell vaccine made from each patient’s own immune cells and tumor. It’s built for cancers that badly need new options. DOC1021 holds FDA Fast Track and Orphan Drug designations for glioblastoma and Fast Track designation for pancreatic cancer.
We’re looking for a Senior CRA to join our Clinical Operations team and help run our randomized Phase 2 DOC-GBM2 study in newly diagnosed glioblastoma.
What you’ll do:
- Lead site qualification, initiation, monitoring, and close-out visits, both on-site and remote
- Oversee complex, high-enrolling sites, including chain-of-identity and chain-of-custody for tumor tissue, apheresis and cell therapy product
- Keep sites compliant with ICH-GCP E6(R3) and FDA regulations, and ready for inspection
- Act as the main sponsor contact for 8–12 sites and mentor junior CRAs
What you bring:
- 5+ years of independent on-site monitoring experience as a CRA, covering all visit types
- Oncology monitoring experience (neuro-oncology or cell and gene therapy is a plus)
- Experience with CTMS, EDC, and eTMF systems
- CCRA or CCRP certification and Lead CRA experience preferred
- Home-based, with 50–70% travel to clinical sites
If you want your monitoring work to move a new kind of therapy forward for patients with glioblastoma, we’d like to hear from you.
👉 Send a copy of your CV to: HR@diakonosoncology.com
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#ClinicalResearch #CRA #Oncology #CellTherapy #Glioblastoma #Biotech #Hiring #RemoteJobs
