Senior Clinical Research Associate
2 weeks ago
We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at Bayside Solutions, Inc. As a Senior Clinical Research Associate, you will play a crucial role in the successful monitoring and management of clinical trials. Your primary responsibility will be to ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements.
Key Responsibilities- Monitor clinical studies of investigational and approved products, including qualification, initiation, interim, and close-out site visits.
- Manage and train site personnel in the therapeutic area, protocol requirements, proper source documentation, and case report form completion.
- Manage and track the preparation and return of investigational supplies at individual sites.
- Monitor and document investigational product dispensing, inventory, and reconciliation.
- Monitor and document laboratory sample storage and shipment.
- Review source data and case report forms for accuracy, completeness, and integrity, and identify and resolve ongoing data issues.
- Review data queries and listings and work with study centers to resolve data discrepancies.
- Review regulatory documentation for accuracy and completeness and support study centers with regulatory issues.
- Maintain complete and accurate study files and review files to ensure all appropriate documentation is present.
- Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
- Phase 1 Oncology experience
- RN, Bachelor's and/or an advanced degree in biological sciences or a related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
- Detail-oriented
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
- Flexibility with changing priorities
- Able to efficiently perform and prioritize multiple tasks
- Familiarity with the medical and pharmaceutical industries and related terminology and practices
- Extensive knowledge of FDA regulations and their practical implementation
- Able to travel, including by air or by car, on short notice
- Computer proficiency in Microsoft Word, Excel, and PowerPoint
CRA, Phase 1 Oncology, FDA, Microsoft Office, travel
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