Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
Implement the monitoring plan as part of the Trial Team.
Deliver Risk-based Site Monitoring approach and local training for the trial.
Behave as local expert and consultant on site management and monitoring topics.
Trial Conduct:
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial
Issue management / oversight on country level.
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the
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info@astrixinc.com