Tamara B. Email & Phone Number

Dublin, Ie

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 SOPs/WPs, applicable regulations, and the principles of ICH-GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Morrisville, Nc, Us

Maintained timely and effective communication among team members and site staff. Identified potential issues and implement corrective actions independently. Planned day-to-day activities for monitoring of a clinical study and sets priorities per site. Assured compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintained current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Responsible for site management and site staff performance including: monitored all types of clinical trials; participate in all types of site visits; assured compliance with all protocol requirements; assure effective patient identification and recruitment plan is in place; assured timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensure proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly review the status of the contents of the site regulatory binder; exhibit superior time management skills.Performed source data verification according to contractual requirements. Assured timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Performed clinical data listings reviews as needed. Completed and submitted reports according to SOP/Work Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintained awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit.Performed additional duties and assignments, as requested.

Morrisville, Nc, Us

• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site. • Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites.• Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum.• Monitors with knowledge of quality/scope and budget parameters. • Escalates issues and feedback for the team.• Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase. • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. • Provides accurate and timely submission of trip reports.• Manages query resolution process with sites and Premier Research Data Management.• Assists project team with assessing project feasibility and recruitment, as applicable.• Maintains project tracking system of subjects and site information as applicable.• Participates in Investigators’ Meeting as designated by Project Manager.• Manages investigative sites via telephone calls between visits.• Ensures adherence to study timeline and budget.• Attends meetings as required. • Performs additional duties and assignments, as requested.

• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents. • Prepares clinical reports of assigned projects for submission to regulatory authorities. • Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters. • Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable. • Leads management of trial(s), including selection of sites, management of the training of study site personnel, planning and oversight regular study meetings, and associated operational activities with conducting and closing out Phase I through Phase III studies. • Assists in the recruitment strategies and enrollment tracking, data analyses and manuscript preparation. • Prepares and completes critical study documents and performs final editing/proofing prior to release of document (e.g. protocol; ICF; IB; monitoring guideline; investigative device/drug labels). • Contributes to the development of Standard Operating Procedures (SOPs), work practices, and clinical guidelines.

• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents. • Prepares clinical reports of assigned projects for submission to regulatory authorities. • Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters. • Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable. • Leads management of trial(s), including selection of sites, management of the training of study site personnel, planning and oversight regular study meetings, and associated operational activities with conducting and closing out Phase I through Phase III studies. • Assists in the recruitment strategies and enrollment tracking, data analyses and manuscript preparation. • Prepares and completes critical study documents and performs final editing/proofing prior to release of document (e.g. protocol; ICF; IB; monitoring guideline; investigative device/drug labels). • Contributes to the development of Standard Operating Procedures (SOPs), work practices, and clinical guidelines.

• Independently and proactively performs CRA responsibilities, such as: maintenance and QC of Trial Master File, review of regulatory documents, Informed Consents, and monitoring reports, and the tracking of invoices and purchase orders. • Key participant in the start-up, implementation, management, and close-out of clinical trials; including preparation of clinical study protocols, CRFs, Informed Consent Forms, clinical study reports, INDs, and New Drug Applications. • Develops presentation materials for and presents at Investigator Meetings, and prepares presentations for and performs Site Initiation Visits. • Assists with development and review of study manuals (monitoring plan, site regulatory binder, pharmacy instructions, etc.). • Performs and documents Qualification, Initiation, Interim Monitoring and Close-Out Visits; reviews monitoring reports generated by CRAs. • May accompany monitors on site visits to monitor CRA performance to ensure adherence to the Monitoring Plan, Protocol, and GCP/SOP compliance. • Provides research and data analysis supporting vendor selection and evaluation, provides recommendations. • Identifies documentation deficiencies and discrepancies and coordinates corrective action as required. • Assists the CTM in the oversight of Serious Adverse Event reporting including documentation, tracking, and follow-up. • Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards.