Clinical Research Associate II with 3+ years for international CRO

September 8, 2013 by
Filed under: Clinical Research 

International CRO:
We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span
the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

Job Title:
CRA II office based in Rome or home-based

Job description:
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Responsibilities:

Tasks may include but are not limited to:

  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Provide input into the design of protocols, CRFs and monitoring plans as requested
  • Assess, monitor, and train study site staff on protocol adherence as required
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems
  • Assist the site in maintenance of the Investigator Site File
  • Maintain regular communication with sites
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Assist sites in data query resolution
  • Ensure site compliance with IP receipt, accountability and return or destruction
  • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
  • Complete final site close out visit and report

Requirements:

  • 3+ years experience
  • Bachelor’s Degree with a scientific background is required
  • Therapeutic areas: preferable cardiology, diabetology, CNS
  • Certification as a CRA needed.
  • Proficient in computer applications
  • Willingness to travel required
  • Valid current passport required
  • Driving license required
  • Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
  • Available asap

How to apply:
Please send your resume to cv.crasecrets [at] crasecrets.com with subject “CRA II – CS 130609”

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