Tamara Steuart Email & Phone Number

Evergreen, Co

Wfh

Provide management, monitoring, and reporting of clinical trials with a focus on patient safety and assuring all study documentation is properly maintained and in compliance with regulatory guidelines. Emphasis on monitoring Phase I clinical trials.

Lenexa, Kansas

Responsible for the successful study management of Phase I clinical studies in the clinic from start-up through study closure.

Kansas City, Missouri Area

Provide management, monitoring, and reporting of clinical trials with a focus on patient safety and assuring all study documentation is properly maintained and in compliance with regulatory guidelines.

Kansas City, Missouri Area

Clinical Research Associate monitoring early phase studies.

Responsible for monitoring site assignments for clinical trials. Assures adherence to GCP, Investigator integrity, and compliance with protocol and all study procedures. Provide management, monitoring, and reporting of clinical trials conducted. Monitoring and reporting of Phase I and Phase II clinical trials. Specialty in Phase I and II studies including first time in man, single and multiple dose escalation, and drug-drug interaction. Primary responsibilities include: Site Management and performance of in-house and on-site monitoring activities for clinical studies;Reviewing protocols and educating site staff regarding study procedures, CRF and query resolution, record keeping, and recruiting strategies;Monitoring clinical trial activities at clinical sites;Conducting site assessment visits, site initiation visits, clinical conduct observation visits, site interim monitoring visits, and site close-out visits;Monitoring of case report forms and electronic data capture systems;Facilitating project timelines;Generating monitoring reports, including the Clinical Monitoring Plan;Assuring compliance with FDA regulations, ICH guidelines, IRB conditions; and SOPs, and assuring all study documentation is properly maintained and in compliance with regulatory guidelines.Additional responsibilities include:Provide Phase I Clinical Trial Systems (PICTS) training to outside monitors; Assist in training new CRAs; andRepresent monitoring department in sponsor driven audits and interview new CRA candidates.Phase I Studies: Alzheimer’s DiseaseNeuropathic painStress related disorders, anxiety, and depressionVaccinationsSchizophreniaConduct disordersArterial thrombosisRenal failureGastrointestinalThrombocytopenic disordersParkinson’s DiseaseEpilepsyALSOpioid DependencePhase I(b) Studies in patient populations:Diabetes MellitusRenal impairment SchizophreniaPhase IV Studies:Treatment of Glabellar RhytidesOsteoporosisParkinson's

As a Sr. Project Coordinator, I performed the following tasks: managed the set up and maintenance of all project documentation files, records, and application files; coordinated all information and communications for assigned projects and updated and maintained internal databases, tracking systems, and project plans with project specific information; prepared and posted updated study information to clients and internal staff to better communication; coordinated project team and customer meetings, identified and planned appropriate medium (Web, telecom, face to face) and ensured arrangements were handled appropriately while determining and planning all meeting requirements in advance; took and recorded minutes, notes and actions at assigned meetings, distributed and followed up accordingly; created and tracked project timelines; coordinated with other project support staff within and across the Global Project Management Unit to identify and consolidate support processes while ensuring that work was conducted in compliance with standard processes, policies and procedures, and met quality and timeline metrics; served as primary backup contact for internal project team and for external stakeholders/customers; assisted the project managers with budget allocation and approval of invoices and undertook project management activities as directed by project manager; point of contact for sponsors/monitors regarding all regulatory documents and regulatory related issues from start of study through close-out, including closure of the Investigator Site File; assisted with review of volunteer/patient data for compliance with protocol and FDA guidelines; prepared document submission to the IRB and prepared and processed correspondence from IRB for submission to sponsors and staff; prepared and processed all regulatory documents for submission to sponsor for IND package; performed special projects as assigned; trained and mentored more junior project support staff.

As an administrative assistant handling regulatory documents, I performed the following tasks: prepared, processed and handled all regulatory documents including but not limited to, FDA Form 1572, Financial Disclosure Form, Delegation of Authority Form, Curriculum Vitae, CAP/CLIA Certification, Laboratory Normal Ranges, Protocol, Investigator’s Brochure, etc. for submission to sponsor for IND package; point of contact for sponsors/monitors regarding all regulatory documents and regulatory related issues from start of study through close-out, including closure of the Investigator Site File (ISF); maintained regulatory database in Access that tracks regulatory documents, including effective date, expiration date and renewal date of CV, medical license, laboratory certifications, etc.; submitted all adverse events to local IRB pursuant to FDA regulations; assisted seven study directors with various administrative tasks, including printing chronologies, disease reporting, preparing power point presentations, IRB submissions, scanning documents, etc; prepared correspondence from IRB for submission to sponsors, study directors and staff; familiar with ICH GCP Guidelines and FDA regulations; assumed responsibilities of Executive Assistant to Dr. Leese as needed (i.e., vacation, medical appointments, sick leave, etc.); created power point presentations and prepared/mailed-out marketing brochures for Business Development; maintained Protocol and Investigator Brochure database and distributed to staff via e-mail notification.

As a patent administrator in the Intellectual Property Department, I performed the following tasks: reviewed, critiqued, prepared, and processed all Material Transfer Agreements; reviewed and docketed all incoming patent prosecution and agreement information stored on docketing database (D.E.A.L.S. and Inteum CS); reviewed and processed all invoices from law firms and prepared invoices for reimbursement from licensees; created and prepared all slide presentations and materials for board meetings, senior staff meetings and Conflict of Interest committee meetings; consulted with law firms and licensees regarding patent prosecution matters; contacted inventors to obtain signatures on formal documents and to discuss agreement matters; prepared docket reports and patent reports for technology transfer office, senior staff and licensees; reported inventions with government funding to NIH through database iEdison and consulted with NIH staff regarding funding matters.

Bachelor'S Degree, Political Science

Political Science