Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.);
Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Project Manager.
Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.
Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.
Qualifications
Degree in Pharmacy or any related course.
1+ years prior monitoring experience with global trials.
Experience with clinical trial set up and contract negotiation preferred, but not essential.
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
