Experience

PAREXEL INTERNATIONAL CLINICAL RESEARCH PRIVATE LIMITED
• India
• 100 - 200 Employee
• Clinical Site Manager

  • Mar 2015 - Present


Duke University Health System

• Hospitals and Health Care
• 700 & Above Employee

• Nurse Manager

  • Aug 2009 - Present

  Oversee hiring, orientation, performance, promotions, scheduling Collaborate in the development, implementation and expansion of learning opportunities and skill development for all staff Promote education for patients, patient families and the community Provide direct patient care, working collaboratively with physicians and mid level providers as a targeted strategy for role modeling or information gathering Identify clinical operational needs, monitor equipment maintenance Assess the environment, patient comfort, safety and compliance with various regulatory bodies (e.g., OSHA, JACHO). Promote effective communication (problem solving, assertiveness, active listening and conflict resolution) Develop and implement processes to enhance clinic operations and practices with ongoing quality and performance improvement. Develop, document, implement and monitor written policies Manage clinic in the absence of the Practice Manager, and be available for emergencies involving the facility, staff members and patients. Show less


North Carolina
• United States
• Technology, Information and Internet
• 1 - 100 Employee
• Registered Nurse

  • Jan 1993 - Present

BLS
• Ukraine
• Commercial and Industrial Equipment Rental
• Cardiac Life Support

  • Jan 1989 - Present


Duke University Medical Center

• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate II

  • Aug 2007 - Aug 2009

  Phase I & II Studies - Cardiovascular and Heart Failure Assist Project Leader with protocol-specific Data Management, Quality Management, Information Technology and Regulatory processes. Evaluate and review monitoring visit trip reports. Monitor and manage sites in accordance with DCRI and sponsor SOPs in compliance with FDA, GCP and ICH Guidelines Co-monitor as mentor for new CRAs Phase I & II Studies - Cardiovascular and Heart Failure Assist Project Leader with protocol-specific Data Management, Quality Management, Information Technology and Regulatory processes. Evaluate and review monitoring visit trip reports. Monitor and manage sites in accordance with DCRI and sponsor SOPs in compliance with FDA, GCP and ICH Guidelines Co-monitor as mentor for new CRAs



Health Decisions

• Software Development

• Senior CRA (Lead)

  • Jan 2007 - Aug 2007

  Phase III Studies - Female Contraception Lead CRA for the Clinical Affairs NIH project team. Supervise 6 CRAs, 1CTA Assist Project Manager with protocol-specific Data Management, Quality Management, Information Technology and Regulatory processes. Manage monitoring resources and project schedule Evaluate monitoring findings and oversee follow-up/resolution. Develop and present clinical education sessions for CRO staff. Provide monitoring field training for developing CRA staff Direct Responsibility for performance evaluation of team members. Develop study tools and instructional material for CRAs and site staff Show less



Duke Clinical Research Institute

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate II

  • Jan 2006 - Jan 2007

  Registry Study: ASAPrepared regulatory submissions for IRBDeveloped source documents and tracking recordsParticipated in the development of the ASA website (DCRI).Recruited Duke satellite clinic trial participationRecruited and enrolled subjects.Coordinated the logistics for 3 associated sub-studiesBrachial reactivity, EPC and platelet aggregationManaged the trial materials budget Worked with Duke faculty to promote the trial and accrue subjects

• Clinical Research Coordinator III (Lead)

  • Feb 2005 - Jan 2006

  Phase II & III Studies - Heart FailureSupervised 5 CRCs and 1 CTAManaged site budget for 18 clinical trialsRecruited and enrolled subjectsPrepared and maintained site-based regulatory documentationEvaluated new studies to match portfolio and resources

• Clinical Research Coordinator II

  • Oct 2004 - Feb 2005

  Phase II & III Studies - Heart Failure Managed 6 clinical research studiesRecruited and enrolled subjectsCollaborated with study monitors using electronic data capture systems (EDC) and Electronic Case Report Forms (eCRFs)Developed and managed Acute Heart Failure Network

• Clinical Research Coordinator II

  • Mar 2002 - Oct 2004

  Phase III Studies - Kidney Failure (NIH)Supervised 1 CTAManaged partnerships with entities outside of Duke Health SystemRecruited and enrolled subjectsPrepared regulatory submissions for the IRBAssisted with a site audit at a site within the consortium Listed as contributing personnel in multiple manuscripts and journal articles

• Advanced Staff Nurse

  • Jun 1998 - Mar 2002

  Associate member of the CCU management team. Directed initiatives related to staff developmentRepresented CCU on DUMC Quality Assurance Committee.Coordinated the delivery of direct patient care



Granville Community College

• United States
• Higher Education
• 100 - 200 Employee

• Nursing School Clinical Instructor

  • Jan 2000 - Jan 2002

  Supervised and taught Associate Degree Nursing (ADN) and Licensed Practical Nursing (LPN) students. Coordinate and co-directed LPN skills lab. Developed lecture syllabus Developed examination content and evaluated student performance in the classroom and clinical settings. Supervised and taught Associate Degree Nursing (ADN) and Licensed Practical Nursing (LPN) students. Coordinate and co-directed LPN skills lab. Developed lecture syllabus Developed examination content and evaluated student performance in the classroom and clinical settings.

• Charge Nurse

  • Jan 1993 - Jan 2002

  Managed nursing and support staff for 16 bed cardiac ICU - 12 hour shift Coordinated bed Control for the ICU and 64 bed step-down unit Collaborated with Cardiology Fellow, Attending Physician and referring hospitals for triage and transportation of patients to Duke Medical Center via Life Care and/or Life Flight. Managed nursing and support staff for 16 bed cardiac ICU - 12 hour shift Coordinated bed Control for the ICU and 64 bed step-down unit Collaborated with Cardiology Fellow, Attending Physician and referring hospitals for triage and transportation of patients to Duke Medical Center via Life Care and/or Life Flight.