Clinical Research Associate, 10/2011
to Current Duke Clinical Research Institute DCRI – Durham,
Assume the role of CRA as assigned, performs clinical trial site management activities, and confirm site compliance with the protocol, applicable SOPs, regulations, and guidelines.
Remain knowledgeable about applicable regulations, guidelines, diagnostics and clinical trials in general.
Continues to participate in clinical monitoring training, both formal and on-the-job.
Monitors assigned sites for compliance to protocol and regulations.
Prepares site visit reports, confirmation letters, follow-up letters and other monitoring documentation as required.
Perform monitoring visits such as PSSV, SIV, PMV and COV's.
Reviews and verifies informed consent process documents, study subject data in case report forms (eCRFs) to source documents, resolves data queries, drug accountability, violations/deviations and data verification as required.
Assists with tracking patient enrollment, site data, eCRF, ICF, as required.
Facilitates the distribution of study materials and supplies to sites.
Attends and participates in weekly project team meeting, supporting the project team(s) in the development of plans and protocols for studies, design and review of informed consent form templates and case report forms.
Contributes site selection materials, site training material, study data, reports, procedural manuals and other project-specific documents with the Project Study Team.
Provides follow-up on deficiencies, maintenance of study files, memos, reports, documents, and coordination of the study.
Clinical Research Coordinator II, 02/2008
to 10/2011 Duke Medical Center – Durham,
Organizing and performing clinical research studies conducted by the Principle Investigator.
Performing activities involved with the collection, compilation, documentation and analysis of clinical research data.
Recruiting and screening subjects appropriate for clinical studies.
Performing all Complete Pulmonary Function Testing required for screening and study visits on all study subjects.
Performing all study required testing for multiple studies per study protocol and maintaining study equipment for site research studies.
Reviewing study documents, protocols, collecting regulatory documents, informed consents, case report forms and source documents.
Preparing and submitting to the Institutional Review Board (IRB) applications until final approval received (initial submission and Amendments).
Preparing, reviewing regulatory SOP's and supporting the PI in fulfilling regulatory obligations.
Clinical Research Associate, 08/2007
to 02/2008 Duke Clinical Research Institute – Durham,
Conduct monitoring visits to ensure the integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of CRFs, source documents, medical records, and regulatory documents.
Provide feedback to sites that will strengthen their GCP and protocol compliance.
Effectively manage sites by identifying root causes for any problems, establishing and communicating a plan for improvement, collaborating with the PI to oversee progress, and following to resolution.
Coordinate the development of protocols, documentation and standard operating procedures for the administration and monitoring the clinical trials.
Train site personnel regarding the trial and GCP, initially and throughout the study.
Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
Conduct retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
Respiratory Care Practitioner and Pulmonary Function Technologist, 07/2006
to 08/2007 Duke Medical Center – Durham,
Responsible for performing respiratory care procedures on outpatients, inpatients and subjects participating in clinical research studies which included
Clinical Educator, 07/2005
to 03/2006 Advanced Home Care – High Point,
Performed patient education on COPD, CHF, Asthma, and Sleep Obstructive Apnea.
Responsible for performing CPAP and BiPaP set-ups on patients in the hospital, home and weekly CPAP Clinics.
Marketed the home health services provided by the company and performed educational in services in High Point, Burlington and Greensboro Pulmonary Clinics.
Assistant Manager of Cardiopulmonary, 07/1988
to 07/2005 Alamance Regional Medical Center – Burlington,
Assisted the Manager with the daily management operations of the Cardiopulmonary Department.
The daily operations included Non-Invasive Cardiology, Neurosensory, Pulmonary Function Lab, Blood Gas Lab, Respiratory Therapy, Bronchoscopy Lab and Pediatric Asthma Center.
Managerial obligations included
Bachelor of Science: Interdisciplinary Studies,
Current Liberty University On-Line - Lynchburg,
VA Interdisciplinary Studies
Associate Degree of Allied Health: Respiratory Therapy,
1 1980 Durham Technical Community College - Respiratory Therapy
Bachelor of Science: Allied Health,
1 1977 Campbell University completed three years - Allied Health
7+ Years Clinical Research Professional: includes Clinical Operations, Clinical Monitoring, and Study Coordination experience Clinical Monitoring Experience: Cardiovascular Infectious disease Pulmonary Oncology Rheumatology Industry and Government Sponsored Trials Experience.
22762, Licensed RCP A-381
ACRP Member and RTP Chapter Member 9/2013
Apple Computers, budgets, Data Management, documentation, Educator, forms, GCP, Internet knowledge, letters, Managerial, materials, MS Excel, MS office, Outlook, MS Power Point, Windows 8, MS Word, Monitors, Organizing, personnel, policies, progress, protocols, quality improvement, Recruiting, recruitment, reporting, research, scheduling, SOP, Vista