Adept professional with extensive clinical research experience. Seeking a career as a clinical research associate (CRA). Excellent knowledge of study protocols, work in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines, Standard Operating Procedures, and guidance documents. Superior writing skills, with ability to prepare proposals, informed consent documents, reports, and IRB submissions.
Research Manager, 04/2014
to Current Georgia Regents University – Augusta,
Analyze budgets, amendments, billing grids, grant applications and ancillary documents for accuracy and completion prior to obtaining hospital approval for clinical research studies conducted at Georgia Regents University and Georgia Regents Medical Center (GRMC).
Assist researchers with preliminary budget and IRB submission questions regarding proposed clinical trials.
Review Pathology, Radiology, Pharmacy and other ancillary service requests.
Prepares study summary documents that go to GRMC administration to assist with their approval of studies in a timely manner.
Provide billing information, including hospital account numbers, CDM codes, and prices for CPT codes to researchers to ensure that Patient Accounting bill studies properly.
Submit study information to Power Trials Administrator to upload into Power Trials, this GRMC clinical trial management system is used to track studies and to access patient's electronic medical records.
Serve as liaison to various research offices regarding budget issues prior to hospital approval.
Maintain several online programs required for document tracking and budget approval.
Demonstrate excellent organizational skills by tracking all project activities in project databases for accurate reporting on clinical trial progress.
Assist with creating SOP's for Research Development Services.
Assist with administrative duties and provide training for new office staff members.
Participates in Human Research Academy, Coordinator orientation, Town Hall Meetings and other research educational forums.
Research Review Coordinator, 09/2005
Provided a quality mandatory review of IRB submissions, budgets and contracts prior to obtaining hospital and IRB approvals for all studies conducted by the Departments of Medicine.
Assisted researchers with preliminary budgets, contracts, and IRB submission questions regarding proposed clinical trials.
Assisted with the preparation of IRB applications, including protocols and informed consent documents and obtained approval to conduct the study.
Maintained appropriate correspondence with the IRB, regarding adverse events, annual renewals and protocol amendments.
Served as liaison to various research offices regarding site issues with budgets and contracts prior to study approval.
Worked closely with the Grants and Contracts Department to define the Clinical Trial Agreements (CTA) language as needed by all parties for each proposed clinical trial.
Demonstrated excellent organizational skills by tracking all project activities in databases to accurately report clinical trial progress.
Reviewed, compiled, and sent feasibility questionnaires to sponsors to qualify for new study opportunities.
Reviewed feasibility questionnaires for completion before submission to sponsors.
Provided regulatory support for studies conducted at the OCIS Outpatient Clinic.
Created and maintained documentation according to SOP's, protocol requirements, FDA GCP's, and regulations.
Assisted with administrative duties and provided training for new office staff members.
Clinical Research Coordinator, 10/2003
to 09/2005 Northpointe Health Center Troy Medical Center – Berkley Troy,
Assisted with the preparation of IRB applications, including submission and informed consents and obtained sponsors approval to conduct the clinical trial.
Conducted telephone interviews to determine subject eligibility.
Scheduled intake appointment to recruit subjects to study.
Obtain informed consent and HIPAA authorization, conducted intake interviews, and enrolled subjects following the protocol established by project sponsors.
Managed multiple studies simultaneously from inception to completion.
Monitored studies to ensure continued compliance with Federal, IRB, and OSHA regulations.
Created informed consent documents for clinical trials, in accordance with Internal Review Board (IRB) standards.
Collected data from patient examinations; prepared medical records for sponsor's clinical report forms.
Responsible for drug accountability for each study.
Maintained extensive patient contact via telephone and written correspondence.
Monitored patients to track follow-up visits; recorded any adverse effects; and compiled participants' opinions regarding study in general.
Demonstrated excellent organizational skills by tracking all project activities in project.
Databases for accurate reporting on clinical trial progress.
Reviewed, compiled, and sent feasibility questionnaires back to sponsors to sites that fit the study indication.
Reviewed feasibility questionnaires for completion before submission to Global Project Manager/Clinical Trial Lead.
Created and maintained documentation according to SOP's, protocols, FDA GCP's, and regulations.
Responsible for clinical communication with central and local IRBs and maintained ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events.
Responsible for clinical tasks including venipuncture, vital signs, body measurements and ECGs.
Working with contracts and budgets with study Sponsors from study start-up through study close-out.
Responsible for the safety and proper conduct of patients throughout the clinical trial.
Maintained source documents and regulatory documentation of clinical trials.
Ensured quality of data on CRFs.
Verified source data/documents and other clinical trial records for accuracy and completion.
Lead Phlebotomist Laboratory Technician I/II, 10/1990
to 10/2003 Wayne State University – Detroit,
Responsible for collecting, processing and shipping research specimens to various outside and local laboratories.
Monitored patient's glucose levels, conducted glucose tolerance and hemoccult test.
Conducted bone density examinations for research studies.
Responsible for laboratory inventory for research study patients.
Demonstrated and trained patients on how to care for their glucose monitors.
Responsible for preparing laboratory supplies needed for medical school students.
Assisted students in various training laboratory procedures.
Calibrated and cleaned all medical equipment needed for training.
Responsible for proctoring examinations to medical students.
Associate of Science: Medical Laboratory Technology,
1 1987 Wayne County Community College - Detroit,
MI Medical Laboratory Technology
Bachelor of Science: Criminal Justice,
1 2002 Wayne State University Georgia Regents University - Detroit Augusta,
MI GA Criminal Justice