职位描述
Job Description
? Assume the ability to meet the requirements of a CTS I with a high degree of proficiency and
autonomy
? Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual
projects
? Train team members on selected tasks
? Mentor and train new staff as appropriate
? Action site selection strategy
? Refine project-specific site selection strategy at a country level
? Identify new potential Investigators and enter/update clean information into the tracking
systems
? Ensure feasibility, review and approval of site identification list coming from FCI
? Conduct country specific feasibility and/or site pre-qualification and/or or remote qualification
visits and/or site selection activities (except for on-site qualification visits, which will be done
by CRAs)
? Create country specific / site specific (if necessary) Informed Consent Form (ICF)
? Review and approve country specific ICFs (if necessary)
? Prepare and negotiate clinical site agreement at a site leve
? Prepare and submit Institutional Review Board (IRB)/Ethics Committee (EC) applications until
final approval received (initial submission / Amendments)
? Customize SRP Guidelines
? Collect and compile regulatory documents in collaborations with the CRA
? On a regular basis conduct outbound and receive inbound calls to:
? Review recruitment plan
? address/resolve issues pending from qualification visit
? address protocol questions
? check on site staff assignment
? request outstanding documents
? Follow-up on appropriate site related questions
? Review and approve SRP
? Immediately update tracking system once regulatory documents are approved
? Adapt drug label for country requirements in cooperation with Regulatory and the Logistics
Team (if applicable)
? Organize translations per country/regulatory/client requirements
? Submit safety updates to IRB/IEC (if applicable)
? Prepare and submit MOH/RA documentation and follow-up until final approval received
(Initial submission/Amendments), where applicable in countries fulfilling responsibilities of
regulatory services
? Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC)
personnel as required
Job Qualifications
Substantial Clinical experience in Clinical Research required
