B.S, Psychology1993Pennsylvania State UniversityPsychology
Education and Compliance CoordinatorJul 2009 to Current University of Pittsburgh － Pittsburgh, PA
Performs routine monitoring of oncology clinical trials conducted under investigator-sponsored Investigational New Drug (IND) applications at the University of Pittsburgh Cancer Institute.
Responsible for performing quality assurance audits of research protocols throughout the University of Pittsburgh.
Organizes and participates in educational programs related to human subject research.
Maintains and disseminates up-to-date information regarding federal regulations and ethical considerations, and IRB policies related to the use of human subjects in research.
Clinical Research AssociateDec 2007 to Jul 2009 CRA Philips Respironics, Inc. / i3 Pharma Resourcing － Monroeville, PA
Contract CRA for i3 Pharma Resourcing at Respironics, Inc.
Transitioned to full-time employee of Respironics, Inc in September 2008.
Develops clinical protocols, product investigator brochures and study informed consent documents.
Supports regulatory submissions for assigned business unit.
Prepares requests for proposals (RFPs) and negotiates budgets and agreements for planned clinical trials.
Organizes product design reviews in preparation for release of investigational devices.
Monitors activities at clinical sites to assure adherence to Good Clinical Practices (GCPs), U.S.
Food and Drug Administration (FDA) regulations and study protocol.
Reviews regulatory documents and maintains sponsor regulatory binder.
Prepares site visit reports.
Assists with site initiation visits, ongoing training and study closure.
Ensures the timely identification and reporting of adverse events according FDA guidelines and standard operating procedures.
Regulatory SpecialistSep 2007 to Dec 2007 University of Pittsburgh Medical Center UPMC UPMC Cancer Centers － Pittsburgh, PA
Developed clinical study protocols, regulatory submissions and various scientific and medical-related reports to contribute to the overall clinical and regulatory effort for oncology trials Prepared and submitted IND applications, amendments and annual reports and SAE reports to the FDA.
Created and submitted scientific reports regarding trial progress, SAE reports, protocol status change updates, and termination reports to the University of Pittsburgh Institutional Review board (IRB) and other regulatory committees as per their guidelines Maintained an organized and assessable regulatory file for site audit/monitoring visits as per UPCI policies.
Maintained the UPCI Clinical Trials Management System (CTMS) database.
Project CoordinatorApr 2002 to Sep 2007 University of Pittsburgh Medical Center (UPMC)
Mental Health Intervention Research Center MHIRC － Pittsburgh, PA
Prepared protocols and informed consent documents.
Ensured that staff and faculty are in compliance with federal and local human subject regulations.
Developed registry protocols for DNA collection and analysis and subject recruitment.
Monitored existing projects for compliance.
Managed multi-site protocols for regulatory compliance including oversight of Data and Safety Monitoring Boards.
Acted as a liaison between investigators and IRB staff to resolve human subject issues.
Program Manager / Clinical Research CoordinatorAug 1998 to Feb 2002 University of California UCSD － La Jolla, CA
Coordinated over 25 phase II-IV clinical drug trials for psychiatric indications in both inpatient and outpatient populations.
Promoted to Program Manager in October 2002.
As Program Manager, supervised junior Clinical Research Coordinators and ensured the execution of clinical research protocols according to IRB policy, FDA regulations and Good Clinical Practices (GCPs).
Prepared and negotiated budgets with sponsor representatives.
Authored literature review publications for anxiety disorders.
Clinical Research CoordinatorOct 1996 to Aug 1998 University of Pittsburgh Medical Center UPMC Western Psychiatric Institute and Clinic WPIC － Pittsburgh, PA
Coordinated a two-year, phase III study examining the efficacy of sertraline in adults with co-morbid depression and alcohol dependence.
CounselorMar 1997 to Jun 1998 Mercy Behavioral Health System － Pittsburgh, PA
Worked part-time as a counselor for a residential facility that served clients with mental illness and developmental disabilities.
Research AssociateMar 1994 to Jan 1996 The University of Pittsburgh Medical Center UPMC Western Psychiatric Institute and Clinic WPIC － Pittsburgh, PA
Investigated the bio-behavioral development of female adolescents with substance abuse and psychiatric disorders.
Administered structured diagnostic interviews, standardized and neuropsychiatric testing.
Barrett CM, Rapaport MH. "Anxiety Disorders" (2001). In DL Dunner & JF Rosenbaum (Eds), Psychiatric Clinics of North America: Annual of Drug Therapy. Philadelphia: WB Sunders, 181-208.
Rapaport MH, Barrett C, "Panic Disorder" (2001). Current Psychiatry Reports, 3: 295-301.