CRA in Japan

Location: Ōsaka, Japan

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Requisition Number: 1238

Position Title: Clinical Research Associate I

External Description:

SUMMARY:                     

Clinical Research Associate I is 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:

  • 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
  • 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 the 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
  • Complete final site closeout visit and report

OTHER SKILLS AND ABILITIES:

  • Good oral and written communication skills
  • Good planning and organizational skills with effective time management
  • Good interpersonal skills
  • Ability to work in an organized and methodical manner
  • Basic understanding of clinical research principles and process
  • Basic understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Basic knowledge of one therapeutic area, sufficient to function as a CRA
  • Good understanding of standard operating procedures
  • Basic knowledge of Microsoft Office
  • Familiarity with IxRS, EDC systems

 REQUIREMENTS:

  • Four-year college degree required
  • Willingness to travel and valid current passport required
  • Driving license required
  • Fluent in Japanese and proficient in both spoken and written English.

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City:

State: Osaka

Employment Type: Regular

Community / Marketing Title: CRA in Japan

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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