Clinical Research Assistant Pulmonary Function Technologist resume example with 15+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Summary
Highly motivated and multi-disciplined healthcare professional with clinical expertise in critical care medicine serving as a lead clinical research facilitator supporting biomedical research studies for the Department of Defense. Superb knowledge and experience with planning, conducting, and managing multiple human subject research trials involving pulmonary disease and SARS-CoV-2. Exhibits a strong leadership approach with an exemplary work ethic.
Core Competencies
Strong clinical background
Military Health
Multi-trial management and organization
Regulatory oversight and compliance
Team Collaboration
Good Clinical Practice
Detail Oriented
Pulmonary Diagnostics
Professional Overview
12/2020 to Current
Lead Clinical Research CoordinatorRadiant Research – San Diego, CA,
Serve as the primary study coordinator for a multi-site clinical trial entitled "Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients with ARDS".
Responsible for implementing, organizing, and conducting highly independent research in direct collaboration with both principal investigators and sponsor while ensuring all tasks are performed within scope of project.
Maintain a collaborative research environment between site personnel, sponsor, clinical research organization, IRB, and study participants.
Responsible for regulatory oversight; subject screening and recruitment, informed consent, subject retention activities, data collection, source documents, binders, and biological specimen management.
Diligent in monitoring the success of the protocol adhering to both institutional and central IRB, federal, and GCP/ICH guidelines to safeguard data integrity, patient safety and confidentiality.
Attend monthly study team meetings providing framework for successful research by establishing responsibilities.
11/2020 to Current
Clinical Research Coordinator IIDrug Information Association Inc – Nacogdoches, TX,
Collaborate with sponsor, investigators and team members to carry out efficient and fully compliant SARS-CoV-2 clinical trials for the Department of Defense in support of the Operation Warp Speed project.
Directly coordinate study visits reviewing eligibility criteria, informed consent, medical history, and preparing subject for study treatment per protocol.
Educate subjects on study responsibilities, duration, possible side-effects, and potential outcomes of the trial while ensuring patient safety and confidentiality.
Perform subject safety follow-up
Responsible for maintaining and auditing source documents, data collection, and query resolution.
Track study protocol deviations and adverse event reporting.
Projects:A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19; Vaccine Effective & Immune Response of SARS-CoV-2 Vaccines in Active Military Personnel (VIRAMP); Epidemiology, Immunology, and Clinical Characteristics of Emerging Infectious Diseases with Pandemic Potential (EPICC)
09/2014 to 11/2020
Lead Clinical Research CoordinatorRadiant Research – Cerritos, CA,
Spearheaded multiple clinical trials involving Pulmonary disorders in project development, management, administrative, regulatory oversight, and compliance.
Effectively monitored all protocols adhering to Institutional Review Board, federal, institutional and GCP/ICH guidelines to safeguard data integrity, patient safety and confidentiality.
Rigorously prepared and maintained all regulatory documentation while meeting deadlines for annual reviews, amendments, timely protocol deviation and adverse event reporting, study audit preparation, new protocol submissions and closures.
Provided regulatory guidance and direction on new study protocols to physicians and other study personnel with all applicable policies regarding human subject research, procedures, and regulations.
Collaborated with Institutional Review Board, OHRP staff and investigators in analyzing, reviewing and editing research protocol submissions ensuring full compliance prior to approval.
Diligently executed all study protocol tasks including participant recruitment and enrollment; protocol eligibility; subject retention; medical chart review; managed participant referrals and scheduled patient visits; lung function diagnostic testing; monitored and evaluated patient response to protocol treatment; data collection and analysis; biological specimen maintenance.
Provided regulatory guidance and direction on new study protocols to physicians and other study personnel with all applicable policies regarding human subject research, procedures, and regulations.
Maintained high quality security measures for all source documents and data files.
Dealt with changing priorities and meeting deadlines with professionalism and accuracy.
Mentored and provided ongoing support to research team, providing training in research design and conduct.
03/2013 to 08/2014
Registered Respiratory TherapistFaith Regional Health Services – Wayne, NE,
Evaluated adult patients in an ambulatory surgical setting with deficiencies and abnormalities within cardiopulmonary system and made medical decisions based on assessments.
Adhered to all standards of excellence established for respiratory care and diagnostic services.
01/2006 to 02/2013
Registered Respiratory TherapistFaith Regional Health Services – Norfolk, NE,
Evaluated both pediatric and adult patients in a critical care setting with deficiencies and abnormalities within cardiopulmonary system and made medical decisions based on assessments.
Strong knowledge and experience in all facets of Respiratory Therapy including all treatment modalities and equipment.
Interacted with patients, family members and physicians to coordinate and inform regarding patient care.
Administered medication and ventilatory support, including maintenance and management of artificial airway and life support systems.
Identified need for medical intervention by determining patient safety risks.
Patient educator on disease processes and management in both inpatient and outpatient settings.
Education and Training
Expected in
Bachelor of Science: Biology/Microbiology Minor Loma Linda University - Riverside, CA, GPA:
Expected in
Associate of Science: Respiratory Therapy Loma Linda University - Loma Linda, CA, GPA:
Certifications
Registered Respiratory Therapist (RRT) board certified by the National Board For Respiratory Care Licensed by the Texas Medical Board.
Current Collaborative Institutional Training Initiative on Biomedical Research, GCP/ICH, and IATA.
Current BLS certified through the American Heart Association.
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