Trial Capabilities Associate

The Trial Capabilities Associate role ensures that patients will have access to our clinical trials with the aim of making life better for our patients. The Associate is accountable for obtaining all approvals (Competent Authority and Ethical Review Board) to run the trial in the Czech Republic. The Associate will also have responsibility to ensure the investigator sites meet the requirement to enrol the study participants in the clinical trial and support maintenance and closeout activities.

• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable),  track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
• Create, review and customization of country/site specific Informed Consent Forms (ICFs).
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Understand and comply with procurements, legal and financial requirements, and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement

Education:

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred

Language

• Fluency in English and Czech language

Experience

• Applied knowledge of project management processes and skills
• 2-5 years’ experience in clinical development, with some experience in clinical research/ Involvement in cross-functional clinical trials/experience in supporting the operational activities of clinical trials.
• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem-solving skills and demonstrated ability to meet timelines.
• Self-management and organizational skills.