(Senior) Clinical Research Associate
Orca Bio(1 month ago)
About this role
The Clinical Research Associate at Orca Bio supports late-stage biotechnology clinical trials focused on next-generation cell therapies for blood cancers. The role monitors clinical studies at investigative sites or remotely to ensure they are conducted and documented in compliance with protocols, SOPs, and regulatory requirements. It includes acting as a primary contact for clinical sites and maintaining high-quality trial documentation. Depending on experience, the position may be scoped as a standard or senior-level CRA.
Required Skills
- Clinical Monitoring
- Site Management
- Interim Monitoring
- ISF Review
- EMR Review
- Source Data Verification
- Adverse Event Review
- Regulatory Compliance
- GCP Knowledge
- FDA Regulations
+18 more
Qualifications
- BA/BS
- 2+ Years CRA Experience
- 5+ Years CRA Experience
About Orca Bio
orcabio.comOrca Bio is a cell therapy company focused on "bringing precision to life" by delivering the promise of cell therapy to patients without compromise. The company develops precision cell therapies and enabling technologies designed to improve safety, efficacy, and scalable manufacturing. Orca Bio combines research, engineering, and robust manufacturing approaches to accelerate clinical translation and bring novel cellular medicines to patients.
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