Kelly Henkel

Project Manager Associate August 2002-April 2003
Project Manager April 2003-October 2005
Sr. Project Manager October 2005-October 2007
Associate Director October 2007-August 2008
•Provide global coordination of client-sponsored Phase I-IV clinical trials across multiple-disciplines.
•Lead project teams, comprising all functional departments and coordinate the project team effort, including, implementation of the project plan throughout each project phase to ensure project milestones are met.
•Ensure overall adherence to scope of work, budget, and study timelines, quality of deliverables, and all other project management activities for the project(s) or program(s).
•Focal point for communication between sponsor and Quintiles to ensure appropriate communication channels are maintained and reporting schedules are adhered to.
•Development of project plans for all phases of the project lifecycle-including proper risk and resource management.
•Develop and implement continuous improvement processes for assigned projects via lessons learned.

•Responsible for the development of monitoring manuals and various study reference materials for monitors and investigative site personnel
•Reviewed and assessed potential investigators via monitoring visits, telephone screens, and credentialing research
•Primary contact for regional monitors regarding project related issues and questions
•Reviewed monitoring trip reports and letters for content, possible site concerns, and proper addressing and resolution to all identified issues
•Provided regional monitors with training regarding project procedures and good monitoring techniques including looping of visits to contain costs
•Co-monitoring with regional monitors to ensure proper monitoring and consistency among monitoring team
•Responsible for the review and processing of regulatory documents from sites
•Responsible for the review and maintenance of study specific databases
•Development of Access Database for team tracking of milestones and study goals met
•Provided regulatory study status reports to sponsor and clinical research organization managers
•Clinical/Data Management liaison to ensure communication between the two groups
•Excellence in Research spot award recipient for outstanding work and dedication to ensuring successful study start-up and running of a 200 site Phase IV Diabetes Study (Dec. 2000 & June 2001)

•Responsible for assisting in writing protocols, preparing study documents and tools and drafting electronic case report forms
•Independently monitored and managed investigative sites (48 sites and 5 protocols across the Southern US) and establish good working relationships with physicians and nurses
•Successfully troubleshot issues related to the conduct of clinical studies and provide suggestions for improving the conduct of future studies
•Trained and educated contract monitors on study specific issues and electronic data capture
•Reviewed electronic Case Report Forms and generate queries by ensuring data collected are consistent and accurate
•Follow-up and reconciled laboratory tests and abnormals
•Approved Investigator sites based on Pre-Study visits and ensure clinical trials are conducted in accordance with Good Clinical Practices and Standard Operating Procedures
•Key Contribution Award recipient for outstanding work and met deadlines with the successful completion of a multi-center, Phase III, clinical study

•Presenter at three national Coordinator Meetings (Topic: FDA Financial Disclosure Ruling)
•Performed CRO QA Compliance audit of three Phase III protocols and one Phase II protocol
•Overview reported subject laboratory values for abnormalities
•Reviewed electronic case report forms for possible errors and querying
•Creation of study tables compiling data to be used with NDA submission to the FDA
•Oversaw two Clinical Research Coordinators and an Administrative Assistant
•Promoted to CRA after 5 months for recognized participation and achievement of department goals and milestones

•Actively participated in the conduct of various tasks prior and during an Investigator Meeting
•Assisted in investigator recruitment
•Responsible for all regulatory document and advertisement IRB submissions
•Verified completeness and accuracy of regulatory documents received
•Maintained subject enrolment, serious adverse event and investigator databases
•Direct site/sponsor contact and correspondence
•Assist CRAs and Project Manager with the audit of study files for sponsor and FDA review
•Implemented and streamlined procedures to achieve improved efficiency and productivity
•Assisted CRAs with typing, proofing, and editing reports and correspondence

•Supervise development clinical tools for global and multi-protocol clinical study teams.
•Serve as consultant on protocol and CRF development and other study documents.
•Collaborate with other functional groups to support milestone achievement and to manage study issues and obstacles.
•Aid teams with resource planning, training and team communication.