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Clinical Monitoring Specialist
2 months ago
About the Role:
The Clinical Monitoring Specialist will be responsible for ensuring the integrity of clinical data and compliance with regulatory requirements at the site level. This will involve conducting monitoring activities in accordance with the Study Monitoring Plan (SMP) and collaborating with the Site Manager to ensure the site is in compliance with the protocol and is inspection-ready.
Key Responsibilities:
Oversight of Monitoring Responsibilities and Study Conduct:
• Ensure regulatory, ICH-GCP, and protocol compliance by evaluating the overall performance of the site and site staff, and providing recommendations for site-specific actions.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject as required.
• Demonstrate diligence in protecting the confidentiality of each subject and assess factors that might affect subject safety and clinical data integrity at an investigator site, such as protocol deviations and violations, and pharmacovigilance issues.
• Conduct monitoring activities using different methods, such as on-site and remote monitoring, as allowed by country regulations.
• Conduct source document review and verification of appropriate site source documents and medical records, including verifying required clinical data entered in the Case Report Form (CRF) is accurate and complete.
• Manage reporting of protocol deviations and follow up as necessary.
• Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilize available hardware and software to support the effective conduct of clinical study data review and capture.
• May perform Investigational Product (IP) inventory, reconciliation, and reviews storage and security.
• Verify the IP has been dispensed and administered to subjects according to the protocol and verify issues or risks associated with blinded or randomized information related to IP.
• Apply knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned.
• Manage reporting of identified issues and follow up to resolution.
• Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
• Ensure all activities are managed by site personnel who are appropriately delegated and trained.
• Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
• Review data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, and timelines for database locks.
• Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date.
• Conduct follow-up for escalated adverse event monitoring (AEM) report queries.
• Check the site and external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable).
• Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log).
Collaboration:
• Collaborate with primary Site Manager who will act as the primary liaison with site personnel.
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
• Participate in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
Process, Standards, and Oversight:
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Requirements:
• A minimum of 1 year experience as a clinical monitor/clinical research associate with demonstrated experience of on-site monitoring.
• Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice.
• Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.
