Senior Clinical Research Associate

• Function operationally as a member of a Project Team
• Initiate, monitor on-site and remotely, and close out clinical study sites
• Monitor clinical trials according to company and sponsor SOPs, GCP/ICH guidelines, and regulatory requirements
• Perform monitoring activities to assess subject safety, data integrity, and quality
• Verify informed consent procedures and protocol compliance
• Review electronic or paper CRFs and subject source documentation
• Verify management and accountability of Investigational Product
• Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, update tracking systems, and escalate issues
• Provide sites with identified issues and required action items
• Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance
• Participate in audit and inspection preparation and follow-up
• Order, ship, and reconcile clinical investigative supplies when applicable
• Update CTMS and project systems with accurate site-level information
• Work dedicated to one global pharmaceutical or biotechnology sponsor

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• At least 3 years of oncology monitoring experience
• Minimum 1 year in Phase I/II oncology studies
• Strong GCP/ICH knowledge
• Fluency in English
• Ability to work in a fast-paced environment with changing priorities
• Ability to work independently and in a team matrix organization
• Strong written and verbal communication skills
• Excellent organizational skills
• Technology savvy and good software and computer skills
• Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail
• Ability and willingness to travel up to 60-80%

• Opportunities for personal and professional growth
• Rewarding work environment
• Collaboration-focused team culture
• Quality-focused culture
• Opportunity to make a difference in patients' lives
• Flexible clinical development and strategic resourcing solutions