CTI
Clinical Research Associate II
Details are still being prepared
This job currently has limited structured detail from the source. You can open the original posting for full description.
What You'll Do:• Serve as main CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP • Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection • Collect, review and track essential/regulatory documents • Participate in and complete all general and study specific training as required • Participate in investigator, client and project team meetings; may include presentations • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP • Assist with project-specific activities as member of Project Team Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.