Public Health Volunteer Resume
Flemington, NJ
SUMMARY:
- Experienced Public Health Member Public Health Environment for 6 years in Volunteer and Graduate Training Programs
- Emergency Management Disaster Drills SAS Studio Training & Exercises
- Health Clinic Support Staff Chronic & Infectious Disease Case Studies
- Disease Outbreak/Surveillance Training Public Health Research Methods
- Disease Prevention Education Presentation & Analysis of Epidemiological Data
SKILLS:
Computer Platforms: Macintosh and PC operating systems; proficient in the use of WebEx, Microsoft Word, Excel, Access, Outlook, Lync, Project, and PowerPoint.
Clinical Trial Software: Proficient in the use of SharePoint, CTMS, eTMF, Lotus Notes, ePortal, Livelink, eSub.
Clinical Data Software: Inform & RAVE EDC systems; Oracle & EndPoint IVRS systems.
Statistical Software: Experience with SAS Studio.
Financial Software: Basware, iProcure, Zendesk, and CFSA softwares.
Drug Safety Software: Received observational training on Argus, MedDRA, and LARS systems.
PROFESSIONAL EXPERIENCE:
Confidential, Flemington, NJ
Public Health Volunteer
Responsibilities:
- Assist local hospitals and health departments with surge personnel needs.
- Participate in mass prophylaxis and vaccination exercises and community disaster drills training with local emergency response partners.
- Participate in health education, vaccination/immunization, & disease prevention/preparedness programs.
- Participate in health clinic support and staffing.
- Test and exercise mass vaccination, mass medication, & quarantine/isolations plans.
- General Emergency Shelter Operations and Support.
- Provide Influenza, Lyme Disease, MRSA, Tuberculosis, Tetanus, and West Nile Encephalitis prevention education to County residents.
- Assist with respirator fit testing for first responders.
- Infectious Disease Epidemiology and Disease Outbreak/Surveillance training and exercises.
Confidential, Summit, NJ
Senior Clinical Trial Associate
Responsibilities:
- Provide operational input on development, management, and maintenance of study deliverables (e.g., timelines, study plans, documents, etc) through collaboration with internal and external stakeholders.
- Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
- Facilitate Aggregate Report production activities across drug safety including PSURs, US PSRs, DSURs, and other safety/clinical reports as required.
- Plan, schedule, and coordinate kick - off, strategy, and resourcing meetings needed for CSR creation.
- Manage TMF set-up, ongoing quality review, and final reconciliation.
- Actively contribute to study meetings including presentation.
- Reconcile IP at study level in collaboration with internal and external stakeholders.
- Ensure full compliance (completeness & accuracy) of the required clinical data in study management tolls including CTMS, patient enrollment forecasting, EDC, etc.
- Proactive identification of potential risk and development of actions to avoid/mitigate.
- Manage vendor and site payment processing along with tracking of payments.
- Assist with maintenance of study budget and reconcile invoices with overall contract/budget.
Confidential, Princeton, NJ
Clinical Research Associate
Responsibilities:
- Preparation of status reports, and organization of investigator meetings.
- Perform CRF review, query generation, & resolution against established data and client clinical data management systems.
- Assist with the generation & reconciliation of queries to investigative sites to resolve problem data.
- Create, update, track, and maintain study-specific trial files, tools, systems.
- Assist in submissions and notification to ethics committees, institutional review boards, and regulatory authorities.
- Review of CRFs, SFN, drug accountability, source data verification, and observation of patient visits.
- Initiate, monitor, & close out investigative sites.
- Participate in company, client, and FDA audits of TMF including responses and resolution to external and internal QA findings.
- Prepare, review, and reconcile the TMF, both paper-based and eTMF.
- Track and follow-up on SAEs, IREs, & ASC forms for completion, accuracy, and submission to drug safety & pharmacovigilance services. QC of PSURs, DSURs, ASRs, and quarterly line listing reports.
- Reconcile CIOMS/patient narrative summary spreadsheets on all adverse events which occur on study.
- Responsible for recruiting investigators, collecting investigator documentation, registry & site management.
- Generate and track investigational drug shipments and supplies.
Confidential, Princeton, NJ
Clinical Research Scientist Intern
Responsibilities:
- Develop, review, and revise protocols, case report forms, training materials, project specific tools, analysis plan designs, investigator brochures, clinical study reports, and new drug applications.
- Participate in scientific and feasibility discussions relating to specific project proposals & site selection.
- Participate in project risk assessment activities.
- Conduct literature searches and reviews.
- Review adverse event reports from drug safety group for completeness, accuracy, and appropriateness.
- Review laboratory values, adverse events, data tables, listings, and figures.
- Assist in the preparation of materials for investigator meetings and other scientific meetings.
- Assist in safety data and scientific interim monitoring and final analysis.