Job Description
Job Summary: - 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.
Responsibilities: - 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.
Job Tags
Interim role, Contract work,