Job Overview :
Collection, review, processing and tracking of regulatory and investigator documents to support Investigator Package submissions and revisions (e.
g. amendments), Ensure ongoing and timely updates of documents and systems
Site contract and budget negotiation
Prepare submissions to IRB / IEC
Collect and track regulatory and investigator documents required for effective and compliant site activation
Ensure Start-up and Maintenance activities are on track and support study deliverables to include providing accurate projections / timelines to study sites, proactive site management, and active participation in team meetings
Ensure high quality site documents are filed in TMF according to study plans
Education / Qualifications :
B.A. / B.S. (Life Science preferred) or equivalent healthcare experience
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.
Strong MS Excel skills required.