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 GROUPSPhiladelphia, PAASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER08/2011 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.
Coalition of Cancer Cooperative GroupsPhiladelphia, PASENIOR PROJECT MANAGER / AUDIT CO-TASK LEADER09/2003 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 RESEARCHPhiladelphia, PAPROJECT MANAGER05/1999 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 COMMUNICATIONSPhiladelphia, PASENIOR CLINICAL RESEARCH ASSOCIATE / CLINICAL RESEARCH ASSOCIATE11/1997 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 Administration1991University of Pennsylvania - Wharton School of Business, Philadelphia, PA
Certifications
Society Of Clinical Research Associates Certification 2005 - 2015
