Clinical Research Associate Oncology Monitoring Specialist
2 days ago
Kelly Science & Clinical is a premier talent solutions provider that connects science professionals with dream jobs. Our team creates expert solutions to solve the world's most critical challenges.
About the RoleWe are seeking an experienced Senior Clinical Research Associate (CRA) to join our team as an Oncology Monitoring Specialist. As a key member of our team, you will be responsible for building and managing site relationships while ensuring subject safety and providing high-quality data review and reporting in compliance with regulatory requirements.
Key Responsibilities- Serve as primary contact for assigned research sites, verifying investigator, staff, and site facilities remain adequate throughout the trial period.
- Responsible for scheduling and conducting pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan.
- Ensure assigned sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
- Verifies rights and well-being of trial subjects are protected.
- Reconciles site regulatory binder, assuring collection and completeness of regulatory documents.
- Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
- Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
To succeed in this role, you should have:
- A minimum of 3 years of experience in on-site monitoring clinical studies, with recent or current oncology experience.
- Strong written and verbal communication skills and interpersonal skills.
- Proficient computer skills, including Microsoft Office, EDC, and CTMS systems.
- Comprehensive knowledge of GCP/ICH guidelines.
- Able to exercise judgment within defined procedures and practices and determine appropriate action independently.
- Attention to detail and problem-solving skills.
The estimated salary for this position is $85,000 - $110,000 per annum, depending on location and experience. Kelly offers eligible employees voluntary benefit plans, including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
About KellyKelly is a global leader in staffing and workforce solutions, dedicated to connecting talented individuals with job opportunities. We pride ourselves on being an equal employment opportunity and affirmative action employer, committed to diversity and inclusion.
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