The Associate Director (ADCR) is responsible for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as releavant local regulations.The ADCR is responsible for line managing a dedicated group of Clinical Research Associates (CRAs) and is responsible for planning and utilization of staff resources, objective setting and performance follow-up.As assigned, the ADCR is responsible for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, as agreed locally.

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

As a Clinical Research Associate, I conducted pre-study, initiation, monitoring, and closeout visits for research sites; performed source document verification and case report form review; performed regulatory document review; conducted study drug or device inventory; performed adverse event and serious adverse event reporting and follow-up; assessed patient recruitment and retention; and served as the initial resource for fielding monitoring-related issues for other CRAs on multiple projects in which I functioned as the Lead CRA.

As a Research Assistant, I actively assisted in data collection for clinical research conducted by the Department of Otolaryngology- Head & Neck Surgery in the Kentucky Clinic. This job recruited study participants, reviewed and obtained informed consent, conducted interviews, scored test results, consulted with nurses and physicians for potential study participants, and facilitated communication with key personnel and participants.