Check with seller Sr. Clinical Research Associate Philadelphia

  • Location: Philadelphia, Pennsylvania, United States

Perform all site development, site set-up, site monitoring, and site close-out activities for specific clinical trial investigator sites in accordance with customer expectations, GSK operating standards, and good clinical practices.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Supports and implements Risk Based Monitoring as directed.
Evaluates the Risk Signals of KRIs along with existing knowledge and experience of investigator sites to support appropriate monitoring intervention, frequency of intervention and areas to focus on during intervention
Participates in study team activities, such as PM lead, reviewer for study documents, user acceptance testing, and all activities requiring the input of CRAs.
Contributes to Investigator meetings by presenting topics or managing interactive sessions with investigator site staff.
Reports out on audit findings, and corrective actions as lessons learned.
Assist in developing the field monitoring organization characterized by process standardization, best practice sharing, and continuous improvement.
Function as the primary site contact between the site staff (i.e., Principal Investigator, Study Coordinator) and GSK. Cultivates and maintains strong working relationships and communication with investigators and GSK staff.
Assume a greater leadership role in the development and implementation of efficient and effective approaches to study site management (e.g. training co-workers and/or contract monitors; coaching/mentoring monitoring colleagues and study staff, as appropriate;

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