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Parexel - Clinical Research Associate Resume Example

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Julian Phillips
XXXXX XXXXX XXXXXX , Hollis , NY 11423 | (H) XXXXXXXXXXXX | XXXXXXXXXXXXXXXXXXXXX
Summary
Seeking a challenging environment where I can use my Clinical monitoring skills to ensure the safety of clinical trial subjects and the credibility of clinical trial data. Committed to providing quality work through dedication and attention to detail as well as proven collaborative and communication skills. 4 years' experience as a Clinical Research Associate Working knowledge of GCP guidelines and FDA regulation Acquires in-depth knowledge of assigned protocol Strong problem-solving abilities, as well as Independent and self-motivated Excellent team player Resourcefully driven Adept with CTMS, EDC, IWRS, and Microsoft Office Exceptional Managerial experience
Skills
  • Active Listening
  • Writing
  • Reading Comprehension
  • Administration and Management
  • Critical Thinking
  • Service Orientation
Experience
Clinical Research Associate 05/2012 to Present
Parexel
  • Acquires solid understanding of therapeutic indications and protocol.
  • Performs co-monitoring visits with less experienced CRAs or at problem sites as required Builds relationships with investigators and site staff Participates in Investigator and other external or internal meetings as required Arranges on-site visits and logistics (e.g.
  • travel arrangements) Performs on site visits in accordance with the monitoring plan Conducts on-site study-specific training (if applicable) Monitors patient safety on-site (review for missing SAEs, AEs,) and address protocol violations Responsible for the completeness and quality of the on-site files Establishes site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit Collaborate with CTL on site issues/actions Generates visit/contact report in accordance with monitoring plan Ships relevant wet-ink signature documents to the Assistant or back to the site Attend audits / Regulatory Inspection if requested.
Project Associate 04/2010 to 05/2012
Parexel
  • Schedule and organize internal, external meetings Provided operational support for delivery of assigned studies on time and within budget Set up meetings, prepare and distributed meeting minutes Assisted in preparing and tracking investigational product supplies, packaging, and shipment requests Maintained site selection set-up and populated the clinical trial monitoring/management tracking systems Assisted in ordering necessary drug and non-drug supplies for clinical trials and processed site requests Prepared or assisted in the preparation of clinical trial agreements and budget payment schedules.
Clinical Research Coordinator 03/2008 to 04/2010
Marian Hospital Carbondale, PA
  • Coordinate and conduct clinical trials in strict guidance of study Protocols and Standard Operating Procedures Obtained informed consent from trial subjects in accordance with study Protocol, GCP guidelines and FDA regulations Monitor subjects and their compliance with the study protocol, Identified and presented AE/SAE to the PI and Sponsors Participate in meetings with sponsors, monitors and regulatory authorities, Assist Investigator in Study Start Up and Close Out Audit Site documents for review by sponsors, monitors and regulatory authorities Performed Subject recruitment, screening and retention, Entered quality data into CRF/eCRF/EDC/IVRS Maintained storage requirement of the Investigational Product and performed Drug Accountability.
  • Collect, process and ship all subject samples according to study laboratory requirement.
Project Manager 05/2002 to 08/2007
Phenom Construction LLc Ellenwood, GA
  • Develop scope of work for Construction project functions, such as design, site assessment, surveying, or field support services.
  • Provide verbal or written project status reports to project teams, management, subcontractors, customers, or owners.
  • Review or evaluate proposals or bids to make recommendations regarding awarding of contracts.
  • Supervise the work of subcontractors or consultants to ensure quality and conformance to specifications or budgets.
Manager 06/1996 to 09/2002
Rite Aid Pharmacy Queens, New York
  • Service provider to customers with RX info and registration.
  • Assisted personnel with customer info refills and pick-up.
  • Management of store accounts and records for entire Pharmacy and store.
  • 5 years of service in customer and personnel relations.
Education
Bachelor of Science: Psychology Jan 2008 KENNESAW STATE UNIVERSITY - KENNESAW, GA
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Resume Details

This is a real resume for a Clinical Research Associate in Hollis, New York with experience working for such companies as Parexel, Marian Hospital, Phenom Construction Llc. 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:

  • Parexel
  • Marian Hospital
  • Phenom Construction LLc

Previous Job Positions:

  • Clinical Research Associate
  • Project Associate
  • Clinical Research Coordinator
  • Project Manager
  • Manager

Schools:

  • KENNESAW STATE UNIVERSITY

Level of Education:

  • Bachelor of Science

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