杭州招聘

Major Accountabilities:
When Assigned to In-House Studies:
Perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities)
Participate in site nomination process, perform evaluation of site capability and make recommendation for inclusion in clinical trial
Point of contact for sites and facilitator of communication between sites and key TY 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
Manage site vaccine supply and sample management during course of study
Ensure site performance in line with milestones and KPIs (i.e. start-up, recruitment, closeout, etc.)
Support investigator in implementing appropriate contingency plans as needed
Assure continual compliance with GCP, ICH and TY 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 COM as required in relationship management tasks (e.g. contracts, sample management, supplies, etc) and evaluating CRO and site performance
Review CRO monitoring visit reports and ensure appropriate follow up and escalation of issues identified; occasionally, co-monitoring with CRAs from CROs

浙江天元生物药业有限公司 诚聘