The Site Monitor Educator is responsible for overseeing and coordinating the activities of site monitors to ensure the successful execution of clinical trials. This role involves ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The Site Monitor Educator will act as a liaison between the clinical trial sites and the sponsor, providing guidance and support to site monitors and ensuring the integrity and quality of the data collected.

Role Type: 6-month contract with a phased-work schedule

Key Responsibilities:

Leadership and Supervision:

• Ensure that site monitors adhere to study protocols, regulatory requirements, and company SOPs.
• Coordinate and oversee site monitoring activities to ensure timely and accurate data collection.

Site Management:

• Develop and maintain strong relationships with clinical trial sites.
• Conduct site visits to ensure compliance with study protocols and regulatory requirements.
• Address and resolve any issues or concerns raised by site monitors or clinical trial sites.

Monitoring:

• Monitoring will entail review of Informed Consent Forms, data entry on the RWE Box folder, Trial master file and source documents.
• Post monitoring of the sites, Site Monitor Lead is to complete site visit reports, File notes and CAPAs and do site retaining as needed.

Quality Assurance:

• Review and approve monitoring reports to ensure accuracy and completeness.
• Implement quality control measures to ensure data integrity and compliance with GCP.
• Conduct regular audits of site monitoring activities and provide feedback for improvement.

Regulatory Compliance:

• Ensure that all site monitoring activities comply with applicable regulatory requirements, including ICH guidelines.
• Site Monitor Educatory to complete regulatory reports and submit to regulatory bodies as required.
• Stay updated on changes in regulatory requirements and industry best practices.

Communication and Collaboration:

• Serve as the primary point of contact between the sponsor and clinical trial sites.
• Facilitate effective communication and collaboration between site monitors, clinical trial sites, and other stakeholders.
• Provide regular updates to the Clinical Operations Manager on the status of site monitoring activities.

Qualifications:

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in clinical research, with at least 2 years in a supervisory or lead role.
• In-depth knowledge of GCP and ICH guidelines.
• Ability to travel as required.

Skills:

• Ability to create and implement effective training programs.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong understanding of pharmacology and medication therapies.
• Excellent communication and interpersonal skills.
• Proficient in delivering engaging and informative presentations.
• Ability to explain complex medical information clearly and effectively.
• Strong analytical and problem-solving skills.
• Attention to detail and ability to work independently.
• Ability to manage multiple priorities and meet deadlines.