中心启动监查员SSU CRA

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.