Clinical trial contractor. Current role as monitor for DFCI on Long Covid trials. Protocol was completed ahead of schedule and data is now being locked.

Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol, and client requirements.• Delivered quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.• Monitored (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.• Prepared for and conducted on-site qualification, study initiation, interim monitoring, and closeout monitoring visits at investigator sites as required by Clinical Monitoring Plan.• Monitored quality/scope/timeline and budget parameters.• Maintained Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines; understanding of the required essential documents according to ICH/GCP Section 8. • Maintained project tracking system of subjects and site information, as applicable.• Maintained communication with study sites, as directed per CMP, and in agreement with the study site and complete documentation of contacts.• Ensured site visit metrics and utilization were maintained and escalated available time, as necessary, to line manager. • Conducted qualification, initiation, interim, and closeout visits at clinical trial sites/investigational sites for clinical studies; responsibilities included identification, selection, initiation, and closeout of appropriate investigational sites for clinical studies.

Conducted identification, selection, initiation, and closeout of appropriate investigational sites for clinical studies.• Monitored sites to ensure studies were carried out according to study protocol, ICON SOPs/WPs, applicable regulations, and the principles of ICH-GCP.• Maintained high level of attention to detail to ensure subject safety for projects and delivery of quality data for clients.• Reviewed site documents and verified accuracy, completeness, timeliness; included required updates.• Reviewed IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan.• Completed all required internal training (general and study-specific) on time.• Acted as resource for other CRAs and shared knowledge base and best practices; contributed to other activities as designated.• Offered involvement, when required, in other areas of study management and staff training.• Contributed to the review of ICON systems and procedures, as appropriate.• Provided coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.• Contributed to the culture of process improvement with a focus on streamlining processes, adding value to the business, and meeting client needs.• Recognized, exemplified, and adhered to ICON's values which centered around a commitment to people, clients, and performance.

Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH/GCP.• Conducted site visits to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, reviewed data to ensure accuracy of data collected and termination of studies.