Clinical Trial Associate

Clinical Research Associate

Location- Durham, NC 27709

Expected Start Date: 02/03/2025 to End Date: 02/01/2026

Job Description

• Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Has knowledge of the therapeutic area and product.
• Participates in CRF development, IVRS set-up, central lab set-up, and other vendor processes set-up, with supervision Assists in the management of vendor performance during conduct of the study.
• Assists in evaluation of vendor performance during conduct of the study. Oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance, with supervision Carries out in house clinical monitoring activities Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
• Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study. Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity
• Reconciles clinical supplies and drug accountability records at study sites
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel 8. Conducts monitor training Assist in the clinical trial management.
• Tracks study specific tasks and progress of the trial
• Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy
• Assists with effective and timely audit/inspection responses
• Performs regulatory document review and approval for IP release
• Monitors processes for distribution and tracking of SAE’s, safety documentation, and pregnancies
• Collaborates with data management to resolve queries
• Facilitates investigator site payments, as applicable
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings)
• Prepares accurate and complete meeting minutes for various meetings.