1. Knowledge & Skills
• Applies knowledge of Company s policies and procedures.
• Demonstrates excellent written and oral communication.
• Demonstrates excellent knowledge of ICH/GCP and relevant local requirements.
• Displays ability to manage investigative sites to facilitate trial deliverables.
• Demonstrates ability to escalate issues appropriately.
• Conducts monitoring to confirm subject safety and data integrity.
• Describes and demonstrates the principals of IP accountability9. Demonstrates working knowledge of Microsoft Office applications.
• Demonstrates excellent knowledge of ICH GCP.
• Identifies scientific misconduct at the site level.
• Demonstrates working knowledge of Clinical Trial Management Systems, e-TMF, IVRS/IWRS and Electronic Data Capture Platforms.
2. Problem solving Fact Finding & Analysis
• Confirms investigative sites are appropriately utilizing protocol and trial process for trial conduct.
• Confirms investigative sites are following ICH/GCP.
• Resolves investigative site issues related to trial. Likely to involve seeking assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management to resolve more complex and difficult issues.
• Demonstrates trial system compliance and skills.
• Resolves investigative site issues related to trial with assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management.
• Utilizes Company systems to analysis investigative site metrics (i.e. backlog, enrollment, protocol deviations, and audits.) to appropriately manage the site.
• Failure to adequately monitor and manage the investigative site could result is endangerment of subjects, safety, none valuable data, and failure to meet project timelines.
4. Supervision Given/Received
• Supervision under the guidance of functional manager, CTM and /or tenured SCRAs.
• Sometimes instruction needed on routine work.
• Undergraduate degree or its international equivalent in clinical, science, or health‐related field from an accredited institution; a licensed health‐care professional (i.e., registered nurse); or equivalent work experience required.
• 2 to 4 years of local trial experience; exposure to MNC and global trials.
Preferred Education and/or Experience
• Clinical research experience.
• Knowledge of ICH and local regulatory authority regulations regarding drug.
• An advanced degree (e.g., M.S.,M.B.A., PharmD, etc.).