杭州招聘

Major Accountabilities (Describe the main results/ responsibilities of the job to be achieved)
When Assigned to In-House Studies:

A Jr. CRA always works under supervision of a CRA, Sr. CRA or COM. May perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities).
After 12 months of experience, may act as point of contact for sites and facilitator of communication between sites and key Novartis line functions
Ensure preparation, collection and distribution of trial master file documents and maintenance of investigator site file
Timely write-up of study monitoring visit reports
Set up and ensure maintenance of investigator site file
May manage site vaccine supply and sample management during course of study - typically after 12 months of experience
Support more experienced colleagues and investigator in implementing appropriate contingency plans as needed
Support more experienced colleagues in ensuring continual compliance with GCP, ICH and Novartis SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, vaccine accountability, and other tasks as specified. Resolve deviations to standard through remedial action and training
Escalate any issues regarding study conduct to his/her manager as needed
When assigned to CRO Trials:

Many of the above responsibilities could still apply but primarily their role in these cases is:
· Support more experienced CRA and CTM as required in relationship management tasks (e.g. contracts, sample management, supplies, etc) and evaluating CRO and site performance
May review CRO monitoring visit reports and ensure appropriate follow up and escalation of issues identified; occasionally, co-monitoring with CRAs from CROs - Typically after 12 months in role