M&A Associate

mason group; Toronto; On-site; CAD 103,000 - 129,000; Full time

Job summary

Mason Group is seeking a clinical monitoring professional to support oncology and phase 1 trials. The role emphasizes regulatory document review, site monitoring, and collaboration across study teams to ensure compliance and data integrity.

Responsibilities include writing monitoring plans, source documents, and trial tools, while ensuring adherence to ICH/GCP guidelines and internal SOPs. The ideal candidate will coordinate site payments and maintain trial-tracking information.

Qualifications

• Knowledge of oncology and phase 1 studies.
• Experience with regulatory document review and regulatory processes.
• Ability to write regulatory/monitoring documents and tools on request.
• Proficient in conducting site monitoring visits and ensuring data integrity.

Responsibilities

• Perform regulatory document review and monitor adherence to document collection processes.
• Write and review monitoring plans, source documents and study tools upon request.
• Conduct monitoring/co-monitoring visits per protocol, laws, regulations and SOPs.
• Identify site findings and implement corrective actions with retraining as needed.
• Verify study documents for completeness and data integrity; track and reconcile supplies and accountability.

Job description

CA$103,348.00–CA$129,185.00 yearly

Full-time +1

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 escape 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.