The CRA/CRC is responsible for the monitoring or auditing of all activities subject to the, “ICH Good Clinical Practice: Consolidated Guideline,” (GCPs), supporting client programs administrated by Watermark ensure project data and summary statements are of known and documented quality.
Will be expected to travel extensively to study sites in the US to monitor our clinical and outcome studies.
Successful applicant must have previous experience monitoring clinical trials.
Basic knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Knowledge/understanding of the approach and perspectives of regulatory agencies.
Essential Skills and Abilities
Good written and verbal communication skills, demonstrated ability to function effectively with all levels of management
Strong negotiation and relationship building skills
Good understanding of medical / corporate governance principles
Detailed oriented and organized