Alma Gutierrez Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

King Of Prussia, Pa, Us

Dublin, Ie

Houston, Tx, Us

Consult and coordinate with Subject Matter Experts in developing work process solutions.Participate in the selection and on boarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct on boarding training for new clinical staff. Implement training programs for clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.Clinical Operations

Houston, Tx, Us

Managed project team and assisted/analyzed their work to meet organization’s objectives and goals. Handled various clinical research projects successfully. Provided training and support to the team membersResponsible for oversight of individual studies as well as relevant program related activitiesManaged escalation of study related issues and establish appropriate course of action with Senior ManagementGuided team to meet clinical program objectivesAnticipating potential study issues and preparing contingency plans with minimal oversightResponsible for the conduct of training and kick-off meetings with sites and vendorsOversaw the development of key team deliverables, such as informed consent forms, study guidelines, operations manuals; Clinical Study Reports (CSRs).

Houston, Tx, Us

Interfaced and liaised with sponsor for progress updates and coordinated with sponsor for all project deliverables within timeframe.Designed project plans according to all contract deliverables.Evaluated work and validated all invoices for clinical projects.Forecasted all financial activity according to capacity planning.Analyzed and recommended improvement to all Clinical Project management processes.Developed and maintained study specific procedures.Coordinated all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer.Served as mentor and provided guidance and training to junior Project Managers and Lead CRAs.

Houston, Tx, Us

Responsible for the organization, coordination, administrative management, monitoring and site management of national and global clinical trials (phase I-IV) according to ICH-GCP, EU or FDA CFR21 (as applicable). Managed and mentored CRA team in carrying out site management in collaboration with project leader and other functional group leaders for execution of all monitoring services. Track of the overall study progress (progress reports) and engage in the management of subcontractors and/or vendors.

Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrityMonitored clinical studies, including the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the dataProvided full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trialsPrepared for and conducted on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sitesMaintained/reviewed regulatory documents