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Investigator Sponsored Trial Project Manager Resume Example

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INVESTIGATOR SPONSORED TRIAL PROJECT MANAGER
Experience
08/2011 to Current
Investigator Sponsored Trial Project ManagerCompany Name － City, State
  • Develop protocol timelines based on the scope of the clinical trial agreement and the project budget Primary liaison between Principal Investigators, Grantors, to ensure effective and timely communication of project progress, issues and action items Clinical trial and informed consent document development Implementation and management of processes to reduce clinical trial time-to-activation Development and implementation of systematic site grading system and site selection process aimed at reducing both the first and last patient-in time frames Investigational New Drug (IND / FDA-1571) application filing and management Review of clinical trial site informed consent documents Management of multi-center regulatory documentation, clinical trial site initiation visits and site activation and SAE and external safety letter reporting Selection and management of third party investigational agent distribution vendors Management of clinical site safety data for inclusion in the IND annual report and DSMB meetings Development and submission of protocol amendments for scientific and IRB review Submission of protocol amendments to participating clinical trial sites and tracking of approval documents Development and implementation of Standard Operating Procedures (SOPs) based on Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines Responsible for the overall execution of IST projects Development of the site study binder and trial master file Review and process protocol exceptions and deviations and obtain sponsor approval.
07/2010 to 08/2011
Clinical Research Quality Assurance SpecialistCompany Name － City, State
  • Perform both internal and external auditing and monitoring of Cooperative Group and Investigator Initiated clinical trials.
  • Participate in decisions on audit outcomes and make recommendations for corrective actions.
  • Provide GCP training to Fox Chase Cancer Center staff as well as participating external sites.
  • Maintain document management and control systems for audit procedures, reports and responses to audits conducted for research supported by Clinical Trials Operations Assist in the development of study specific case report forms.
  • Participate in site initiation visits to provide training on case report form completion, investigator responsibilities, and Good Clinical Practices Prepare written summary reports for all monitoring visits.
  • Maintain document management and control system for monitoring procedures, summary reports, and correspondence with investigator sites.
  • Develop, implement and maintain standard operating procedures for FCCC Quality Assurance activities.
10/2007 to 07/2010
Sr. Clinical Research AssociateCompany Name － City, State
  • Complete case report forms for various disease sites and trial phases Second eligibility verification Resolve data queries Develop internal case report forms CTMS and EDC Training Mentor for new staff Develop and refine SOPs.
08/2004 to 10/2007
Principal and General ManagerCompany Name － City, State
  • Management of day to day operations.
  • Responsible for development of operational standards.
  • Contract Negotiations.
12/2002 to 08/2004
Data ManagerCompany Name － City, State
  • Responsible for Phase I clinical trials.
  • Completed case report forms.
  • Prepared charts for monitor review.
05/2000 to 11/2002
Clinical Research AssociateCompany Name － City, State
  • Responsible for cooperative group and industry sponsored clinical trial management.
  • Eligibility verification Data completion Informed consent process Adverse event evaluation SAE reporting Informed Consent Development.
04/1997 to 09/2000
Pharmacy TechnicianCompany Name － City, State
  • Fill patient medication orders Prepare and Inspect Code Carts Inventory Control and Expiration Monitoring Prepare IV medications Delivery of medications to patient care areas of the hospital.
Education
1 2012
BS: Business AdminstrationStrayer UniversityBusiness Adminstration
1 2010
SoCRA Certified (CCRP) 2002: City of Hope National Medical Center - Oncology Clinical Trials Training Program 2000: NJ Department of Health and Senior Services EMT-B Certification
1 2000
A.S: General ScienceBurlington County CollegeGeneral Science
1 1998
Pharmacy Technician Certification Board: Certified Pharmacy Technician (CPhT) 1996: Burlington County College - CPhT Training Program Publications
Skills
auditing, binder, budget, charts, Contract Negotiations, Delivery, Department of Health, document management, documentation, filing, forms, GCP, Good Clinical Practice, IND, Inventory Control, meetings, Mentor, 2000, processes, progress, Publications, Quality Assurance, reporting, research, safety, scientific, Technician, written
Professional Affiliations
Member, Society of Clinical Research Associates (SoCRA) Member, Drug Information Association (DIA)
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Resume Overview

School Attended

  • Strayer University
  • Burlington County College

Job Titles Held:

  • Investigator Sponsored Trial Project Manager
  • Clinical Research Quality Assurance Specialist
  • Sr. Clinical Research Associate
  • Principal and General Manager
  • Data Manager
  • Clinical Research Associate
  • Pharmacy Technician

Degrees

  • BS : Business Adminstration
    SoCRA Certified (CCRP) 2002: City of Hope National Medical Center - Oncology Clinical Trials Training Program 2000: NJ Department of Health and Senior Services EMT-B Certification
    A.S : General Science
    Pharmacy Technician Certification Board: Certified Pharmacy Technician (CPhT) 1996: Burlington County College - CPhT Training Program Publications

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