Clinical Research Associate
New
O
Orca BioBiotechnology
We are recruiting for two roles: one based on the West Coast and one based on the East Coast.Full-TimeMiddle
Salary90,000 - 140,000 USD per year
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Job Details
- Experience
- 2+ years of CRA experience
Requirements
- BA/BS or equivalent degree
- Minimum 2+ years of CRA experience
- Strong working knowledge of FDA and ICH/GCP regulations and guidelines
- 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 preferred), CTMS, and other vendor systems
- Strong interpersonal, verbal, and written communication skills
- Ability to multitask, prioritize, and work under tight deadlines
- Highly detail-oriented with a focus on quality control
Responsibilities
- Serve as the primary monitor and main point of contact for assigned clinical sites
- Conduct interim monitoring visits (IMVs) and ISF review
- Review electronic medical records (EMR) and perform source documentation verification (SDV)
- Verify adverse events, serious adverse events, and concomitant medications for accurate reporting
- Provide support to site staff including research coordinators and physicians
- Assist in the development of trial materials such as case report forms and site tools
- Author and submit high-quality monitoring visit reports within required timelines
- Ensure completeness and accuracy of monitoring documentation in the eTMF
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