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Providence Holy Cross - Clinical Research Associate Resume Example

Harper Bailey
XXXXX XX XXXXXXX XXX XXXX, Rancho Palos Verdes, CA 90275 | (H) XXXXXXXXXXXX | XXXXXXXXXXXXXXXXXXXXX
Professional Summary
Skills
Experience
Clinical Research Associate 06/2015 to Present
Providence Holy Cross Mission Hills, CA
  •  Currently serving as an Interim Clinical Research Manager within the department of clinical research.
  • Monitor Quality Assurance reports, prepare findings' rosters for data transparency on Oncology trials, (Breast and ovarian cancers).
  • Manage Junior CRCs/ Preliminary Screeners for Potential trials.
  • Manage all aspects of Clinical Data Management, including creation and collection of Source documents, completion of case report forms, and tracking/reporting of serious adverse events.
  • Capture/ enter data into clinical trial data base as necessary.
  • Collect and maintain complete records and statistics on each research study patient.
  • Consolidate clinical data and reports for physicians and investigators as needed.
  • Manage patient in follow up on treatment trials, patients on non-treatment, retrospective and repository trials (including screening, eligibility review, consenting and ensuring completion of all protocol-required assessments).
  • Manage the collection of bio specimens for research projects and clinical trials conducted within Providence Health System.
  • Attend Investigators meetings/various study related meetings.
  • Serve as a resource liaison for investigators and other researchers involved in the day to day management of patients on clinical trials.
  • Liaise with sponsors when applicable and coordinate study drug shipments and accountability.
  • Setup monitoring visits and address monitoring reports Assist with quality control audits to verify the accuracy, completeness and confidentiality of research data.
  • Report and address findings as appropriate.
  • Assist in the establishment and maintenance of procedures and systems Assure ongoing informed consent process and patient advocacy during the process according to guidelines per Federal Office of Protection Human Subjects.
  • Assure ongoing compliance with all system, regulatory, federal regulations and department policies.
  • Maintain confidentiality standards for all potential and enrolled patients, comply with federal HIPAA regulations.
  • Contracted In House Clinical Research Associate I.
Clinical Research Coordinator 08/2014 to 01/2015
Edwards Life Sciences Irvine, CA
  • Data review and analysis of study binders and folders using Clinical Trial Data Systems.
  • Review Site selection/ Initiation Visit documentation like Investigator, sub Investigator, coordinators/Nurses CVs and licenses, Lab Certificates, IRB roster, Financial Disclosures and authorizations, Site Staff training logs and all mandatory documentations.
  • Source Document verifications and creating queries.
  • Review IRB approvals, notifications and member lists.
  • Review Informed Consent form, amendments and their approvals with IRB/IEC.
  • File and update all the disclosures and authorizations.
  • Manage Regulatory Binders and Site Binders.
  • Contracted (Oncology).
Hematology Clinical Research Associate II 02/2014 to 08/2014
The Angeles Clinic & Research Institute Los Angeles, CA
  • Clinical Data Management using EDC/RDC applications like Medidata RAVE, Inform, Oracle and TAO.
  • Monitored Multiple Oncology protocols including Melanoma, Lymphoma, Bladder, Lung and Breast cancer studies Consented and enrolled subjects, Entered data, addressed queries etc.
Quality Contorl Scientist II Lead Scientist 01/2009 to 10/2012
LA Biomed @Harbor UCLA Medical Center Torrance, CA
  • Register eligible patients, manage the studies, extract, compile and submit data, monitor study compliance.
  • Monitor and maintain ongoing regulatory requirements.
  • Coordination of specimen collections and documentation.
  • Download, copy, file and distribute protocols and amendments Worked independently and as a team player to meet deadlines.
department's Lead Scientist 08/2002 to 11/2005
Bachem Inc Torrance, CA
  • Performed qualitative and quantitative wet chemical analysis on peptides, including HPLC testing, chromatography for analytical studies, assay titrations, etc.
  • Reviewed and created SOPs and protocols Reviewed QC specifications and batch records Managed and verified department's adherence to GMP, ICH guidelines under FDA regulations.
  • Being part of FDA and Internal audit.
Education
Clinical Research Conduct & Management Certification: UC Berkeley - San Francisco, CA
NIH Human Protection Certification IATA Certification CITI Training Certification Medidata Rave, Inform, Oracle and TAO Certification.:
Bachelors of Science: University of Sindh Pakistan -
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Resume Details

This is a real resume for a Clinical Research Associate in Rancho Palos Verdes, California with experience working for such companies as Providence Holy Cross, Edwards Life Sciences, The Angeles Clinic & Research Institute. This is one of the hundreds of Clinical Research Associate resumes available on our site for free. Use these resumes as templates to get help creating the best Clinical Research Associate resume.

Previous Companies:

  • Providence Holy Cross
  • Edwards Life Sciences
  • The Angeles Clinic & Research Institute

Previous Job Positions:

  • Clinical Research Associate
  • Clinical Research Coordinator
  • Hematology Clinical Research Associate II
  • Quality Contorl Scientist II Lead Scientist
  • departments Lead Scientist

Schools:

  • UC Berkeley
  • University of Sindh Pakistan

Level of Education:

  • Clinical Research Conduct & Management Certification
  • NIH Human Protection Certification\nIATA Certification\nCITI Training Certification\nMedidata Rave, Inform, Oracle and TAO Certification.
  • Bachelors of Science

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