Job Description

• Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols.
• Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary.

• Has a solid knowledge of the therapeutic area or a therapeutic background, showing adeptness to work in oncology and phase 1 studies.
• Performs regulatory document review and monitors adherence to the regulatory document collection process.
• Able to write clinical monitoring plans, source documents, and create other study tools when requested.
• Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance with all relevant laws, regulations, guidelines, protocols, and internal SOPs/policies.
• Identifies and effectively documents site findings with the ability to re-train, place corrective action in place with the site, and follow up as required.
• 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 the 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.
• Collaborates with data management to resolve queries.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
• Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies.
• Monitors compliance with these processes.
• Facilitates investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Obtains a complete understanding of all trial-related documents and operational procedures.
• Maintains clinical trial tracking information pertaining to the study (e.g., monitoring calendar, monitoring reports, phone contacts).
• 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.
• Communicates and interacts with relevant study personnel, including developing and maintaining 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 the study manager; troubleshoots and follows up on study progress; and reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.
• Prepares key reports and documents on the progress of the study for the study manager.
• Tracks study-specific tasks and progress of the trial.
• Reviews study and/or site-specific ICF(s) for compliance with ICH/GCP and company SOPs.

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