Site Navigator Job Overview
This role involves serving as a local expert in project start-up activities for Portugal.
Key Responsibilities:
* Conduct site identification and feasibility studies to determine suitability for clinical trials.
* Negotiate agreements with sites, focusing on securing contracts that meet requirements.
* Coordinate document collection and data organization required by regulatory authorities.
* Serve as the primary contact for investigative sites and ensure timely document collection.
Essential Skills and Qualifications:
Minimum 2 years of experience in clinical development or start-up/regulatory process. Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations. Familiarity with investigator start-up documents and contract negotiation processes. Previous interaction with operational project teams and investigative sites.
Education Requirements:
University degree (life science preferred) or certification in a related allied health profession from an accredited institution. 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.