Lantheus is seeking a Clinical Trial Associate to support the operational aspects of multiple clinical studies across all stages of a trial, ensuring the success of the company's medical imaging and diagnostics portfolio.
Requirements
- General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
- Advanced knowledge of clinical study processes
- Intermediate understanding of the Trial Master File reference model and the ability to navigate an eTMF (Veeva Clinical Vault experience preferred)
- Highly proficient in MS Office applications
- CCRP training / certification (preferred)
- Minimum of 1-2 years experience in clinical research in industry (sponsor or CRO) is required
- Bachelor’s degree in science or related field
Responsibilities
- Develop, setup, and maintain study tracking tools for assigned trials to monitor study progress
- Prepare and maintain study progress data as appropriate (e.g., Key Performance Indicators), and prepare study progress reports as necessary
- Manage clinical study documents including reviews for completion, accuracy, and expiration
- Coordinate the collection and review of essential documents to authorize initial investigational product shipment and site activation
- Conduct periodic quality assessments of a vendor managed Trial Master File for outsourced studies
- Support the maintenance of the Trial Master File for sponsor-generated documents, and assist in quality assessments as appropriate
- Participate in CRF development and edit check testing
Other
- Education: Bachelor’s degree in science or related field
- Minimum of 1-2 years experience in clinical research in industry (sponsor or CRO) is required
- Well organized and detail oriented with strong written and verbal communication skills
- Effective time management and organizational skills
- Significant attention to detail
