Note: The job is a remote job and is open to candidates in USA. Zachary Piper Solutions is seeking a Clinical Research Associate (CRA) to support oncology-focused clinical trials for an organization in the life sciences and pharmaceutical research industry. The role manages and monitors clinical trial sites, conducts qualification and monitoring visits, ensures regulatory and protocol compliance, verifies trial data and documentation, and collaborates with cross-functional teams. It is fully remote with occasional travel to investigative sites.
Responsibilities
- Oversee and manage oncology clinical trial sites to ensure protocol compliance, data integrity, patient safety, and adherence to GCP, and SOPs
- Conduct site qualification, initiation, interim monitoring, and close-out visits for oncology clinical trials
- Ensure clinical trial activities are conducted in compliance with ICH-GCP, FDA regulations, and study protocols
- Review and verify source data, case report forms (CRFs), and regulatory documentation for accuracy and completeness
- Identify, document, and follow up on site issues, protocol deviations, and corrective action plans
- Serve as the primary point of contact for investigative sites, providing ongoing training and support
- Collaborate with cross-functional teams including Clinical Operations, Data Management, and Project Management
- Prepare detailed monitoring visit reports and maintain accurate trial documentation
Skills
- 3+ years of experience as a Clinical Research Associate monitoring interventional clinical trials
- Hands‑on experience performing onsite monitoring for oncology studies, ensuring GCP compliance and inspection readiness
- Direct oncology trial monitoring experience is required
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical research best practices
- Experience conducting remote and on-site monitoring visits independently
- Excellent organizational, communication, and problem-solving skills
- Ability to travel occasionally to investigative sites as required
Benefits
- Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
- Fully remote work environment with occasional travel
Company Overview
Company H1B Sponsorship