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Clinical Research Associate
Location
United States
Posted
80 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate
Orca
• Responsible for monitoring the progress of clinical studies, either at investigative sites or remotely • Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements • Conduct interim monitoring visits (IMVs) and ISF review • Review electronic medical records (EMR)/patient data • Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting • Provide support to site staff including research coordinators and physicians • Assist in the development of trial materials as needed • Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates • Author and submit high-quality monitoring visit reports within required timelines • Ensure completeness and accuracy of monitoring documentation in the eTMF
Job Requirements
- BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior)
- Therapeutic experience in oncology/hematology and cell and gene therapy preferred
- Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
- Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Experience with Trial Master File management according to the DIA reference model
- Experience operating within various site EMR/EHR systems
- Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place
Benefits
- Competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Subsidized daily lunches and snacks at on-site locations
- Pre-IPO equity and annual bonus
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