Senior Clinical Trial Monitor
Há 6 dias
This role involves conducting on-site monitoring activities at investigator sites to ensure compliance with clinical trial protocols and regulatory requirements. The successful candidate will apply a risk-based monitoring approach, utilizing root cause analysis (RCA) and critical thinking skills to identify site processes failures and implement corrective/preventive actions.
Duties and Responsibilities:- Monitor investigator sites to ensure adherence to clinical trial protocols and regulatory requirements;
- Apply risk-based monitoring approach to identify potential site processes failures and implement corrective actions;
- Conduct physical inventory and records reviews to ensure investigational product accountability;
- Document observations in reports and letters, using approved business writing standards;
- Maintain regular contact with investigative sites to confirm protocol adherence and resolve issues;
- Participate in investigator meetings and contribute to the identification of qualified investigative sites;
- Ensure compliance with ICH-GCP and applicable regulations throughout the trial lifecycle;
The ideal candidate will possess a bachelor's degree in a life sciences related field or equivalent experience. Previous experience as a clinical research monitor is highly desirable, along with relevant formal academic/vocational qualifications. A valid driver's license may be required for certain roles.
Benefits:This role offers a dynamic and challenging work environment, with opportunities for professional growth and development. The successful candidate will have the chance to make a significant impact on the success of clinical trials and contribute to the advancement of medical knowledge.
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