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Barbara Gloersen – RN, MS CCRC

PROFESSIONAL EXPERIENCE:

May 2005-Current Clinical Project Management Consultant, Kinexum Metabolics, Inc. Minneapolis, Minnesota

Responsible for the preparation of a clinical development plan for a biologic product in adult onset diabetes mellitus. Developed and reviewed Phase 2 and 3 clinical study protocols, informed consents, case report forms, study timelines and budgets. Reviewed and interpreted clinical trial interim analyses and data listings. Developed Diagnostic Monitoring Committee (DMC), Event Adjudication Committee and Steering Committee charters and Initiated and managed committee meetings. Prepared serious adverse event narratives for phase 3 neonatal sepsis and rheumatoid arthritis trials. Prepared the integrated safety summary as part of a Pre-NDA meeting with the FDA for an adult onset diabetic pharmaceutical product.

2002 - June 2005 Clinical Research Manager, Novoste Corporation Norcross, Georgia

Responsible for the on-time completion of clinical trials. Development and review of protocols and case report forms (CRFs). Management and coordination of Data Management project activities (review and approval of data management plans and data base and edit specifications) and Biostatistical Operations (review and approval of statistical analysis plans and report tables and listings). Responsible for training, conducting co-monitoring visits, and supervising contract Clinical Research Associates. Compiled and interpreted study and site-level tracking data for subjects and CRF status reports. Planned and implemented project team meetings. Reviewed and interpreted interim analysis data listings. Negotiated budgets and contracts with contractors. Coordinated data reporting of central research laboratories for the analysis of radiographic and ultrasound images. Collaborated with the Regulatory Department in the preparation of the clinical sections of IDEs, PMAs, and annual reports. Conducted audits of contractors to assure compliance with trial protocols, ICH and GCP Guidelines, and the Code of Federal Regulations. Coordinated with Quality Assurance for the response to audits and implementation of appropriate follow-up actions.
Responsible for designing and implementing the safety surveillance program for human clinical trials sponsored by Novoste, Corp. Generated and modified safety standard operating procedures (SOPs) that ensure the professional activities of the safety department are consistent with GCP Guidelines and other regulatory requirements. Developed SOPs and managed Data Monitoring Committees (DMCs) for pre-marketing significant-risk device trials. Developed and implemented SOPs for the Medical Information Department, including procedures for scientific literature review and the communication of Novoste product information to external customers.