Responsibilities include: acting as the functional lead from clinical operations with oversight of, and overall accountability for site selection; site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans. Overall responsibility for managing the clinical operations project team and ensuring compliance with SOPs, study contracts, budgets and quality standards.

Responsibilities include: acting as the functional lead from clinical operations with oversight of, and overall accountability for site selection; site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans. Overall responsibility for managing the clinical operations project team and ensuring compliance with SOPs, study contracts, budgets and quality standards.

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOP’s/WP’s, applicable regulations, and the principles of ICH-GCP. Involvement, when required, in other areas of study management and staff training. Contribute to the review of ICON systems and procedures, as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Contribute to the culture of process improvement with a focus in streamlining our processes, adding value to our business, and meeting client needs. Recognize, exemplify, and adhere to ICON’s values which center on commitment to People, Clients, and Performance. Independently and proactively coordinate the necessary activities required to set up and monitor a study.

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOP’s/WP’s, applicable regulations, and the principles of ICH-GCP. Involvement, when required, in other areas of study management and staff training. Contribute to the review of ICON systems and procedures, as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Contribute to the culture of process improvement with a focus in streamlining our processes, adding value to our business, and meeting client needs. Recognize, exemplify, and adhere to ICON’s values which center on commitment to People, Clients, and Performance. Independently and proactively coordinate the necessary activities required to set up and monitor a study.

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON's SOP’s/WP’s, applicable regulations, and the principles of ICH-GCP. Involvement, when required, in other areas of study management and staff training. Contribute to the review of ICON's systems and procedures, as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Contribute to the culture of process improvement with a focus in streamlining our processes, adding value to our business, and meeting client needs. Recognize, exemplify, and adhere to ICON’s values which center on commitment to People, Clients, and Performance. Independently and proactively coordinate the necessary activities required to set up and monitor a study.

Assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing general administration and project tracking support. Assist the clinical operations team in completion of all required tasks to meet departmental and project goals. Escalate study issues to CRA and PM in a timely fashion. Stay familiar with ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems. Set up, organize, scan, upload, file, and maintain clinical study documentations including preparation for internal/external audits, reconciliations, and archival. Send original documents to the sponsor on a monthly basis. Assist project teams with trial progress tracking by updating Clinical Trial Management Systems. Contact Clinical sites for specific request regarding missing documents and updates. Assist in tracking and distribution of safety reports. Attend project team meetings and generate meeting minutes and agendas. Also perform other duties as assigned.

Trained new employees on pharmacy computer systems, filling prescriptions, and proper drug accountability. Provided exceptional customer service. Conducted monthly cycle counts to ensure proper drug control.