Study Monitor

Study Monitor - Clinaxel, United States of America

Clinaxel is part of a group of Animal Health Contract Research Organizations servicing the global animal health industry.

We're actively seeking a North American based Study Monitor to join our expanding Field Clinical Trials team. This role provides the flexibility to work remotely, with occasional office visits required to Waverly, New York and Fort Collins, Colorado.

Primary Job Purpose

Responsible for performing monitoring activities to ensure clinical trials are conducted in compliance with study protocols, VICH GL9 GCP guidelines, and applicable regulatory requirements. The role involves verifying data accuracy, ensuring site adherence to timelines and quality standards, and supporting the overall success of clinical trials.

Key responsibilities include serving as the primary contact for assigned study sites, training site staff on protocols and compliance, and identifying and addressing site-level issues. By maintaining high standards in monitoring practices, this role contributes to the integrity of clinical trial outcomes and advancement in animal health.

Job

Specific Duties and Responsibilities

• Conduct routine site monitoring visits across all trial phases to ensure compliance with study protocols, GCP guidelines, and regulatory requirements.
• Verify the accuracy and completeness of data collected at study sites, identifying and resolving discrepancies as needed.
• Serve as a point of contact for assigned study sites and investigators, facilitating communication and addressing site-level issues.
• Assist in the preparation and review of study-related documentation, including monitoring reports and site records.
• Provide guidance and support to site staff on study protocols, compliance requirements, and best practices.
• Document and escalate risks or issues that may impact study timelines or data quality to the appropriate stakeholders.
• Ensure site adherence to established timelines, quality standards, and budgetary constraints.
• Maintain accurate and organized records within the study master file for assigned sites.
• Collaborate with the team members to support smooth trial operations and successful study outcomes.
• Promote adherence to organizational policies, ethical research practices, and regulatory standards at all times.
• Provide guidance, technical support and training to Assistant Monitors, Monitor Associates, and peers where applicable.

Qualification, Training and Experience Requirements

• Bachelor's degree in a relevant Life Sciences field.
• Minimum of two years' experience in GCP study monitoring within Animal Health or Human Pharma sectors.
• Solid understanding of clinical monitoring processes, including site initiation, routine monitoring visits, and close-out activities.
• Familiarity with regulatory guidelines such as VICH GL9 GCP and their application in clinical trials.
• Strong technical writing and oral presentation skills in English.
• Competence in Electronic Data Capture Systems.
• Demonstrated exceptional organizational and project management capabilities.

Important Note to Applicants

This is a remote position with potential for regular travel.

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