Clinical Research Coordinator
Resume:
Helena McClenahan
Lockport, NY *4094
************@*******.***
HIGHLIGHTS OF QUALIFICATIONS
Served in the United States Air Force with an Honorable Discharge
Over 10 years of experience in the Clinical Research Coordinator field
Certified with OSHA, NIH, HIPPA and others
Great leadership skills and attention to detail
Works well individually or in a team environment
PROFESSIONAL EXPERIENCE
Clinical Research Coordinator (2007 – 2024) – Worked in following departments:
Pulmonology and Cancer
Cardiac and Neurology
Endocrinology and Pulmonology
Genetics / Infectious Disease
Allergy / Immunology and Rheumatology
Gastroenterology
Hypertension and Renal Research
CLINICAL RESEARCH RESPONSIBILITIES
Obtained informed consent from subjects that meet the criteria for the study.
Recruited subjects into study by finding eligible subjects in the Electronic Medical Record system and meet with subjects to inform them about the studies available to them.
Collected blood sampling by performing phlebotomy procedure using aseptic technique and packaging all samples using IATA specifications.
Created source documents from the protocol for each individual subject binder.
Managed current CRF’s, medication assessment and chart reconciliation, AE/SAE data collection and reporting, producing own source documents following protocol visits as required.
Maintained regulatory documentation, submitted new projects, amended existing projects.
Assisted Director of Research with budgeting and reported to the IRB and Principal Investigator monies available to fund studies.
Controlled regulatory documentation; submission of new studies, amending existing studies, annual renewal and safety to the local and central Institutional Review Boards as needed.
Corresponded with study sponsor companies and monitor to assure studies run efficiently.
Formulated for and participated in sponsor audits and regulatory inspections.
Collaborated with principal investigator in preparation of proposed clinical trials which involved review trial protocol, contacted each department to provide resources during study and ensured appropriate departments are notified and provided a copy of proposed trial.
Acted as a liaison between principle investigator and sub-investigator on all regulatory issues and changes within the protocol.
Met with IRB with annual renewal and safety reporting procedures.
Communicated as principle investigator with sponsors, their representatives, the IRB, and other pertinent medical personnel.
Supervised Dialysis Staff in the proper implementation of the protocol to ensure safety of patients enrolled in research studies.
Managed source documentation for Case Report Forms required by the protocol.
Reviewed medical records for potential study patients and ensured that medical records include documentation of all laboratory test results, procedures, and progress of study patients set forth by the protocol sponsors.
Formulated for and participated in sponsor audits and regulatory inspections.
Maintained up to date CRFs, source documentation, medication assessment and chart reconciliation, AE/SAE data collection and reporting, to enter into various Electronic Data Capture: IBM, RAVE, ICON.
Complied with quality assurance, infection control, HIPAA, and policies/procedures of the company.
Used computer-based system, IXRS, as a way of abstaining medication for a patient in the study.
CERTIFICATIONS
OSHA, Blood borne Pathogens
IATA Certification
HIPAA Certification
Cardiopulmonary Resuscitation
NIH Certification 2016
CITI Training Certification
Patient Care Certification (Star Technology Institute – 2005)
Phlebotomy, Medical Terminology, EKG
MILITARY
United States Air Force
Honorable Discharge
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