● Under general supervision, serve as Single Point of Contact (SPOC) in
assigned studies for investigative sites, Site Activation Manager (SAM),
Project Management team, and other departments as necessary. Ensure adherence
to standard operating procedures (SOPs), Work Instructions (WIs), quality of
designated deliverables and project timelines.
● Perform feasibility, site ID, start up and site activation activities
according to applicable regulations, SOPs and work instructions. Distribute
completed documents to sites and internal project team members.
● Prepare site documents, reviewing for completeness and accuracy.
● Ensure accurate completion and maintenance of internal systems, databases
and tracking tools with project specific information.
● Review and provide feedback to management on site performance metrics.
● Review, establish and agree on project planning and project timelines.
Ensure monitoring measures are in place and implement contingency plan as
needed.
● Inform team members of completion of feasibility, site ID, regulatory for
individual sites.
● Review, track and follow up the progress, the approval and execution of
documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form
(ICF), and Investigator Pack (IP) release documents, in line with project
timelines.
● Provide local expertise to SAMs and project team during initial and on-going
project timeline planning.
● Perform quality control of documents provided by sites.
● May have direct contact with sponsors on specific initiatives.