Investigator Sponsored Trial Project Manager Resume Example Fox Chase Cancer Center

INVESTIGATOR SPONSORED TRIAL PROJECT MANAGER

Experience

08/2011 to Current

Investigator Sponsored Trial Project ManagerFox Chase Cancer Center － Philadelphia, PA

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 SpecialistFox Chase Cancer Center － Philadelphia, PA

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 AssociateFox Chase Cancer Center － Philadelphia, PA

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 ManagerSatcomm, LLC － Burlington, NJ

Management of day to day operations.
Responsible for development of operational standards.
Contract Negotiations.

12/2002 to 08/2004

Data ManagerFox Chase Cancer Center － Philadelphia, PA

Responsible for Phase I clinical trials.
Completed case report forms.
Prepared charts for monitor review.

05/2000 to 11/2002

Clinical Research AssociateEligibility Verification Virtua Health Memorial Hospital － Mount Holly, NJ

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 TechnicianRegulatory Coordination Virtua Health Memorial Hospital － Mount Holly, NJ

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)

Resume Overview

Companies Worked For:

Fox Chase Cancer Center
Satcomm, LLC
Eligibility Verification Virtua Health Memorial Hospital
Regulatory Coordination Virtua Health Memorial Hospital

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

Investigator Sponsored Trial Project Manager Resume Example

Resume Score: 90%

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