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Responsibilities:

• Collaborating with Project Manager to set targets for clinical monitoring staff, and ensuring the recording of trial in compliance with project goals.
• Creating and implementing study-specific clinical monitoring tools and documents.
• Creating and overseeing the trial budget.
• Identifying, enlisting, and choosing sites, and coordinating site management activities.
• Coordinating and supervising clinical monitoring team.
• Providing Clinical Research Associates with project-specific training and having regular meetings with them.
• Recording and sharing interactions with clients, and acting as their representative.
• Arranging and overseeing site visits.
• Gathering and examining trial documents.
• Assuring compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.