Note: The job is a remote job and is open to candidates in USA. Piper Companies is seeking a Phase I Oncology Clinical Research Associate to support early-phase oncology clinical trials within the biotechnology and pharmaceutical industry. The role is ideal for a clinical research professional experienced with first-in-human and dose-escalation oncology studies.
Responsibilities
- Monitor Phase I and first-in-human oncology trials in compliance with ICH-GCP and FDA regulations
- Conduct site initiation, monitoring, and close-out visits
- Ensure subject safety, data quality, and protocol adherence
- Review source documents, EDC data, and safety reports
- Collaborate with sites and internal clinical teams to resolve issues
Skills
- 3+ years of onsite monitoring as a CRA with a focus on Phase I or early-phase oncology
- Bachelors Degree is Required
- Hands-on experience with dose-escalation and DLTs
- Strong knowledge of GCP, FDA regulations, and monitoring best practices
- Experience with oncology indications and EDC systems
- Ability to travel to research sites as required
Benefits
- Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
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