Senior Clinical Research Associate, Sponsor Aligned, Oncology

Senior Clinical Research Associate, Sponsor Aligned, Oncology

Overland Park, United States of America | Full time | Field-based | R1541483

Join our dynamic team as a Clinical Research Associate! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patients' lives.

Key Responsibilities Site Monitoring Visits: Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines. Subject Recruitment: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met. Training & Communication: Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues. Quality Assurance: Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed. Study Progress Management: Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local regulations. Reporting: Generate visit reports, follow-up letters, and other necessary documentation. Mentorship: Mentor clinical staff through co-monitoring and training visits. Collaboration: Work closely with study team members to support project execution.

Qualifications Education: BS degree required; a degree in a scientific discipline or healthcare is preferred. Experience: 3+ years of on site oncology monitoring experience strongly preferred. 1.5+ years of oncology monitoring experience can be considered. Phase 1 oncology experience is required.

Skills: Proficient in GCP and ICH guidelines. Strong therapeutic and protocol knowledge in Phase 1 oncology trials. Excellent computer skills, including Microsoft Office and mobile devices. Effective communication, organizational, and problem-solving abilities. Strong time management skills. Ability to build and maintain effective working relationships.

Why Join Us? Be part of a team that's pushing the boundaries of cancer research. You'll have the opportunity to work on cutting-edge Phase 1 oncology trials, collaborate with top professionals in the field, and contribute to life-changing advancements in cancer treatment. If you're passionate about making a difference and have the expertise we're looking for, we'd love to hear from you!