Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Review documents for completeness, consistency and accuracy, under guidance of senior staff.
Prepare site documents, reviewing for completeness and accuracy.
Inform team members of completion of regulatory contractual and other documents for individual sites.
Distribute completed documents to sites and internal project team members.
Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Requirements
Bachelor's Degree Life science or related field Req
With 2 years’ experience in a healthcare environment or equivalent combination of education, training and experience.