Senior Clinical Research Associate

• Function operationally as a member of a Project Team
• Initiate, monitor on-site and remotely, and close out clinical trial study sites
• Monitor clinical trials according to company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations
• Perform monitoring activities to ensure subject safety, data integrity, and quality
• Verify informed consent procedures and protocol compliance
• Review electronic or paper CRFs and source documentation for validity and accuracy
• 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 other project systems with accurate site-level information

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• At least 3 years of experience monitoring clinical trials in Oncology, including at least one early-phase study (Phase I or II)
• Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas
• Understanding of Good Clinical Practice regulations and ICH guidelines
• Ability to work independently and in a team matrix organization
• Strong written and verbal communication skills
• Fluent in English
• Excellent organizational skills
• Technology savvy with good software and computer skills
• Ability and willingness to travel up to 60–80%, including overnight and abroad travel if applicable

• Competitive compensation package
• Comprehensive benefits
• Personal and professional growth opportunities
• Lunch vouchers
• Health insurance
• Pension
• Car allowance where applicable
• Collaborative and innovative work environment