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ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER Resume Example

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ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER
Professional Overview
Experienced Project Manager with strong oncology clinical research background and excellent communication skills demonstrated by > 15 years experience working within government and industry sponsored trial structures and a CRO environment. Proven record of reliability and strong ability to effectively liaise across pertinent areas of team participation. Detail-oriented with solid organizational skills and proficiency in working independently and within team environments. 
Skill Highlights
  • Strong written and oral communication
  • Effective clinical team and trial management
  • Microsoft Word, Excel and PowerPoint
 
  • Training and orientation capability
  • Extensive multi-site national trial experience
  • Problem analysis and resolution ability
Project Highlights
  • Coordinated and/or led 12 working groups ensuring the continued trajectory of complex trial development
  • Successfully solicited, tracked and collated nomination materials for > 300 national oncology leaders resulting in the selection of 45 principal investigators for nationwide precision medicine trial
  • Worked with underserved population and patient advocacy committees resulting in successful protocol changes
  • Successfully led office preparation for 3 sponsor audits
  • Co-developed company CRA monitoring plan/procedures, collaborated with CTMB on site audit guidelines
  • Established an electronic filing system for project activities
  • Recognized by NIH for collaborative input to restructure the NCI National Clinical Trials Network
  • Formulated and/or provided input on >20 surveys to ensure study viability and appropriateness
  • Appointed as representative on company committees: Standard Operating Procedures, Employee Recognition
  • Integral team member for Medidata Rave data management system development
Professional Experience
COALITION OF CANCER COOPERATIVE GROUPS Philadelphia, PA ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER 08/2011 to 07/2015
  • Senior project management of a national multi-faceted collaborative genomic profile oncology trial
  • Review protocols, case report forms and informed consent for development of new studies
  • Joint oversight of federal audit program to assure clinical trial adherence stipulated by CTMB
  • Augment audit team as a site auditor, when necessary
  • Generation of monthly audit statistic report for all NCI funded trials sponsored by participating CTSU members
  • Coordinate and manage project trial teams including clinical operations, data management, monitoring and regulatory compliance
  • Develop project SOP tracking and timeline adherence
  • Responsible for implementing supplemental accrual efforts; i.e. newsletters, surveys, site correspondence, patient and physician directed information
  • Maintain project status and fiscal reports for all managed studies.
  • Ensured meeting minutes accuracy through precise documentation and electronic file maintenance.
  • Ensured proper confidentiality agreement documentation 
Coalition of Cancer Cooperative Groups Philadelphia, PA SENIOR PROJECT MANAGER / AUDIT CO-TASK LEADER 09/2003 to 08/2011
  • Oversee manual patient randomization process and provide guidance to site participants regarding study eligibility determination
  • Data query resolution process oversight
  • Developed departmental electronic file system
  • Tracking metrics for results
  • Participated in SOP development and ongoing team educational training
  • Ensured efficacy of protocol due diligence through auditor and monitor trip report assessments.
  • Primary contact for routine protocol efforts across departments
  • Manage and identify study appropriate sites through use of performance metrics and feasibility surveys
PREMIER RESEARCH Philadelphia, PA PROJECT MANAGER 05/1999 to 07/2001
  • Effectively manage industry supported projects
  • Monitor the project timeline, budget, and resource allocation.
  • Interact and routinely communicate with Sponsor relative to daily operational issues.
  • Maintain current knowledge of federal regulations pertaining to clinical research in accordance with GCPs and company SOPs.
  • Provide assistance in the development of systems and procedures for the department.
  • Track and analyze performance metrics for projects under responsibility.
  • Manage clinical staff for projects under responsibility and ensure the quality of their work.
  • Review written communication from clinical staff under supervision.
  • Assist with the continued professional development of staff within area of responsibility.
  • Prepare monthly study status reports for company and sponsor SAE tracking and site follow-up.
  • Oversight of all project related duties including: investigative site identification, regulatory document process, monitor visits, case report form and source document input and review, and drug accountability and reconciliation.
PREMIER RESEARCH of SCP COMMUNICATIONS Philadelphia, PA SENIOR CLINICAL RESEARCH ASSOCIATE / CLINICAL RESEARCH ASSOCIATE 11/1997 to 05/1999
  • Managed Clinical Research Associates for all aspects of monitoring: including monitor report review, co-monitoring of sites, if necessary and point of contact for escalation of identified site problem.
  • Created and maintained monthly study newsletter and pamphlet.
  • Conducted clinical monitoring visits for oncology and other trial types in accordance with company and sponsor SOP's and standard GCPs.
  • Investigative site identification, drug accountability and reconciliation review.
  • Detailed monitoring visit reports generated and maintained within trial master file system.
Education and Training
Bachelor of Arts: Business Administration 1991 University of Pennsylvania - Wharton School of Business, Philadelphia, PA
Certifications
Society Of Clinical Research Associates Certification  2005 - 2015

REFERENCES
Available Upon Request
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Resume Overview

Companies Worked For:

  • COALITION OF CANCER COOPERATIVE GROUPS
  • Coalition of Cancer Cooperative Groups
  • PREMIER RESEARCH
  • PREMIER RESEARCH of SCP COMMUNICATIONS

School Attended

  • University of Pennsylvania - Wharton School of Business

Job Titles Held:

  • ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER
  • SENIOR PROJECT MANAGER / AUDIT CO-TASK LEADER
  • PROJECT MANAGER
  • SENIOR CLINICAL RESEARCH ASSOCIATE / CLINICAL RESEARCH ASSOCIATE

Degrees

  • Bachelor of Arts : Business Administration 1991

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