Experience

CirQuest Labs, LLC

• Director of Operations

  • Sep 2009 - Present

  CirQuest Labs, LLC is a specialty-biotech CRO/laboratory and life sciences services company located in Memphis, TN. As the chief clinical operations officer, I am currently responsible for assisting with business development, exploring new revenue opportunities, marketing, budget and proposal preparation, project management, and pharmaceutical and medical device regulatory guidance.



Medtronic Spine & Biologics

• Medical Device
• 100 - 200 Employee

• Sr. Manager, Clinical Affairs

  • Jan 2006 - Aug 2009

  • Responsible for performance management, staff development, annual performance evaluations and compensation planning for direct reports• Hiring manager for open positions associated with cost center’s projects• Responsible for budget planning, tracking, and reporting for projects• Assist with project planning• Management of supervisory and individual staff responsible for multiple IDE studies in enrollment, follow-up, or post-approval phases• Responsible for self-development in areas such as: project management and leadership effectiveness • Responsible for review and approval of annual progress reports to FDA• Responsible for communication (i.e., written/telephone) with FDA reviewers• Experience with FDA site audits and assisting sites to respond to findings• Managed clinical data preparation for PMA applications• Participated in PMA panel meeting preparation resulting in recommendation for product approval and eventual product approval• Experience with transitioning IDE studies into the post-approval phase with emphasis on both patient and site retention• Experience with Contract Research Organizations (negotiating proposals, budgets, communication, planning and executing projects according)• Collaborate with key opinion leaders to address clinical questions• Attend scientific society meetings as required to meet with clinical investigators• Meet with clinical investigators to address compliance issues• Travelled internationally to monitor ongoing device trial

• Manager, Clinical Affairs

  • Nov 2004 - Jan 2006

  • Responsible for performance management, staff development, annual performance evaluations and compensation planning for direct reports• Hiring manager for open positions associated with cost center’s projects• Assisted with budget planning and tracking for projects• Assisted with project planning and management • Responsible for review and approval of annual progress reports to FDA• Planned and delegated tasks associated with investigator meetings• Managed Clinical data preparation for PMA applications• Participated in PMA panel meeting preparation resulting in recommendation for product approval and eventual product launch.• FDA audits, CAPA• Management of staff responsible for several active IDE studies either in enrollment or follow-up phases• FDA site audits (prep for) and responses, warning letters, CAPA• Attended scientific society meetings as required to meet with clinical investigators• Travelled internationally to monitor ongoing device trials

• Supervisor, Clinical Affairs

  • Sep 2003 - Nov 2004

  • Assisted with performance management, annual performance evaluations, and compensation planning for direct reports• Training new CRA/Sr. CRA level staff• Collaborated cross-functionally (i.e., with Regulatory, Biostatistics, Key Opinion Leaders, Product Development/Engineering) in the development of US IDE protocol• Responsible for adhering to progress reporting requirements to FDA• Wrote and coordinated sponsor’s responses to multiple FDA deficiency letters• Assisted with ongoing study activities for current IDE projects (i.e., discrepancy resolution, review of adverse event narratives, interim monitoring)• Travelled internationally to monitor ongoing device trials

• Sr. Clinical Research Associate

  • May 2003 - Sep 2003

  • Planning and presenting Clinical information (i.e., study overview, FDA information) at Investigator meetings and participating in Study Coordinator training sessions (i.e., case report form completion, adverse event information)• Conducting investigational site initiation visits with study staff and assisting with interim monitoring• Data management (i.e., discrepancy resolution, safety/adverse events)• Planning for and participating in corporate audits, and understanding the corrective action/preventive action (CAPA) process to address any findings• Participated in the training of new CRA level staff• Travelled internationally to monitor ongoing device trials

• Clinical Research Associate

  • Sep 2001 - May 2003



Baptist Memorial Hospital - Memphis

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Clinical Research Study Coordinator

  • Jun 1998 - Sep 2001

  • Responsible for patient enrollment and data collection for pharmaceutical and device trials primarily related to myocardial infarction, congestive heart failure, and coronary artery bypass grafting surgery• Attended meetings provided by study sponsors• Developed source documents for accurate and complete data collection• Interacted with Investigational Review Boards to obtain approval to conduct clinical protocols• Extensive interaction with various medical professionals (i.e., physicians, nurses, x-ray technicians, laboratory technicians)• Chosen by two study sponsors to speak at multiple national meetings to present techniques and strategies that made enrollment and conduct of study successful at Baptist Hospital• Responsible for educating hospital staff about clinical studies and research• Attended Association of Clinical Research Professionals conferences

• Intensive Care Registered Nurse

  • Jul 1996 - Jun 1998

  • Intensive care unit staff nurse responsible for the care of critically ill patients• Experience with nursing care of multiple disease pathologies• Extensive experience recovering patients receiving coronary artery bypass grafting surgery• Charge nurse responsible for shift management and patient care of 8 to 10 bed intensive care unit during a 12 hour shift• Float charge nurse responsible for shift management, patient assignments, and assistance with patient care for 40 bed intensive care unit during 12 hour shift• Member and chairman of the Performance Improvement committee responsible for coordinating and conducting monthly meetings, delegating tasks of the committee, ensuring completeness of committee activities, and completing the year-end reports



University of Mississippi Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Laboratory/Research Technician - Physiology/Biophysics

  • May 1990 - May 1996

  • Provided support for experimental protocols investigating the neuro-hormonal control/regulation of blood pressure• Managed laboratory organization and operation• Prepared and maintained animals (canine) for long-term, instrumented studies involving cardiac, hemodynamic, and renal monitoring• Administered anesthesia and assisted during surgeries• Knowledge of physiological experimental design and technique• Understanding of laboratory safety standards and USDA rules and regulations regarding the care and use of laboratory animals• Operation and maintenance of a high performance liquid chromatography (HPLC) system and various other analytical laboratory equipment• Proficiency with Microsoft Word, Excel, PowerPoint, and basic statistical/analytical and graphics programs required to produce tables and charts from both presentation and publication• Trained new laboratory staff • Contributed to and co-authored publications in scientific journals



Sports Medicine Fitness and Rehabilitation Center

• Physical Therapy Assistant

  • Sep 1988 - May 1990

  • Assisted patients in clinical/hospital settings with physical therapy modalities• Maintained treatment and fitness equipment in proper and working order• Constructed orthotic inserts and instructed patients on the care and use of the product• Represented the hospital and fitness center at local health fairs and exhibitions