Clinical Research Coordinator I, Urology
Emory University
Associate Clinical Development Medical Director, CV
Kerr Dental
full-time
Posted on:
Origin: • 🇨🇭 Switzerland
Visit company websiteJob Level
Lead
About the role
- Accountable for all country clinical/medical aspects associated with programs/trials and providing clinical strategic and tactical leadership
- Gather, inform, and act on clinical/medical/scientific insights for trial concept sheets, protocols, and ICFs to optimize trial implementation
- Drive identification and involvement of qualified investigators and clinical recruitment activities to overcome recruitment hurdles
- Accountable for adherence to safety standards and clinical data quality in the country and provide clinical/medical support for safety findings
- Collaborate with clinical trial operations, Medical Affairs, and Patient Engagement to support study start-up, recruitment, and mitigation plans
- Validate study designs and make final decision on clinical/medical trial and program feasibility in the country
- Provide clinical/medical expertise for IRB/EC interactions and decide on site/Country-specific ICF content and patient language
- Interact with external experts (Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups)
- Develop clinical/medical trial plans, provide indication/compound/protocol training, and decide on recruitment strategy
- Support planning and follow-up of Regulatory Authority inspections and internal audits, review and resolve Country trial-related issues
- Support Global Clinical Development on protocol deviations and may assess Country datasets for innovative study designs
Requirements
- MD/DO or equivalent
- Training in cardiology preferred
- Knowledge and clinical training in siRNA desirable
- Ability to review and interpret clinical study protocols and assess feasibility
- Apply detailed understanding of drug, disease processes, populations, and standards of care
- Ability to assess feasibility based on Country medical practice and Clinical Development Plan
- Ability to train site personnel and evaluate protocol compliance and patient safety
- Understanding of Regulatory requirements, SOPs, policies, procedures, and guidance documents
- Expertise to represent the company as safety expert to Regulatory Authorities, Health Boards, and REB/EC
