Monitored investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entriesProvided mentoring and support to less experienced members of the project team and advice on training and quality issues.Assisted colleagues with site visits and site calls, when neededServed as resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues

Worked closely with the CTM to coordinate the activities of CRAs on the project team to ensure clinical deliverables are met.Monitored investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entriesRecommended processes to Clinical Management that optimize the use of project resourcesProvided mentoring and support to less experienced members of the project team and advice on training and quality issues.Served as a resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues

Assured adherence to Good Clinical Practice, investigator integrity and compliance with all study proceduresResponsible for the supervision of all direct reportsDeveloped training plans and assured orientation and training were scheduled for direct reportsMentored and coached CRAs in cases where training and performance needs are identifiedEnsured target CRA utilization were metAssisted project management in the quarterly evaluation of and feedback on team members'individual job performanceEstablished and monitored quality and performance expectations on an ongoing basisAssisted with interviewing and assessing initial training needsAttended Business Development Hand-Off and Kick-Off Meetings for projectsReviewed the study scope of work, budget, and protocol contentPrepared and presented materials related to clinical operations for Investigator MeetingsProvided training to CRAs on protocol, CRF completion, sponsor SOPs, and clinical plans and guidelines for the study

Completed project activities associated with monitoring functions of Phase I-IV Clinical Research Studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulationsProvided clinical and technical support for CRA I, CRA II and administrative staffPerformed management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)Performed duties as Lead CRA on projects providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader

Rescue Project: Performed routine site visits to the National Cancer Institute at NIH for Bristol Myers SquibbResponsibilities with minimal supervision included monitoring of proper informed consent procedures in compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements to assure good site performanceDetailed review of subject records, essential documents, as well as site personnel procedures

Performed routine site visits, including pre-study, initiation, interim, and closeout visits for GI and Ophthalmology StudiesManaged assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirementsMentored and trained other junior team members or incomings CRAsMaintained Clinical Trial Management System (CTMS) and Access systems or alternative project tracking databases of subject and site information

Performed routine site visits, including pre-study, initiation, interim, and closeout visitsReported to Ingenix project team, client and site personnel any findings noted during monitoring visitsThis was accomplished by completion of monitoring reports and follow-up letters within the project-specific timelinesMaintained eClinical or alternative project tracking system of subject and site informationParticipated in company-required training programsPerformed necessary administrative functions (eg, tracking of expense reports, time and attendance) as well as other duties as assigned

Participated in the conduct of Multi-Center Clinical Research Studies and assisted in investigator recruitmentEvaluated, initiated, monitored and closed out sites according to applicable SOPs and FDA regulationsReviewed case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirementsResolved CRF discrepancies and/or clarifications via site visit, telephone, or fax as deemed appropriate for the studyPerformed drug accountability, reported adverse events promptly and verified completeness of critical documents