Bachelor's degree in life sciences or a related field
Experience as a Clinical Research Associate or in clinical monitoring (oncology/phase 1 preferred)
Strong knowledge of ICH/GCP guidelines, regulatory requirements, and study protocols
Excellent documentation and communication skills with willingness to travel
Requirements:
Conduct monitoring/co-monitoring activities for interim site monitoring and closeout visits, ensuring compliance with applicable laws, regulations, guidelines, protocols, and internal SOPs/policies
Identify and effectively document site findings, retrain staff, implement corrective action at the site, and perform follow-up as required
Verify study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity; reconcile clinical supplies and drug accountability records at study sites
Prepare site visit reports (PSV, SIV, IMV, COV), telephone contact reports, confirmation letters, and follow-up letters to accurately document site status and activities; communicate with study personnel and support milestone achievement
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.
