Clinical Trial Monitor
📋 Role Overview & Responsibilities
Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions. The company is looking for a clinical trial monitor to join the team.
Job Description:Execute monitoring plans and ensure quality of monitoring by CRAs for assigned US trials (~5-8), considering study complexity and stage.Conduct on-site visits to evaluate CRA performance and oversee assigned trial CRAs.Implement monitoring plans and oversee clinical monitoring deliverables in operations system(s).Develop and deliver Risk-based Site Monitoring approach and local training for the trial team.Assist in-site inspection readiness and lead US site regulatory inspections preparation.Participate in Trial Team meetings, Investigator Meetings, and provide timely responses to inquiries from stakeholders.Oversee Site Management and Monitoring activities by CRO partners, ensuring compliance with ICH-GCP and regulatory requirements.
Qualifications:Education: Bachelor’s Degree in: Health Sciences, Health Care, Nursing, or related field.Minimum of 5 years of experience in on-site monitoring, or 8 years of relevant business experience in pharmaceutical or healthcare industry, (including on-site monitoring experience).Experience with CAPA, risk assessment methodologies, and experience with dermatology or oncology is a plus.
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This position is located in Ridgefield, CT with potential relocation and sponsorship assistance depending on candidate qualifications.
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