Job

JOB

About CRA (Clinical Development, Clinical Research, PMS Monitoring)

Our Clinical Research Associate monitor whether the process for developing new drugs, medical devices, as well as regenerative, cellular therapy and gene therapy products, therapies, etc. (as in clinical trials) and the process of collecting data when new drugs, etc. are administered to a wide range of patients upon approval (as in PMS/post-marketing surveillance) are appropriately conducted according to various laws, regulations, ministerial ordinances (such as GCP/GPSP) and protocols.
To provide the latest medical care to patients appropriately and as quickly as possible , the Clinical Research Associate plays a key role in accurately grasping the status of the assigned project and smoothly advancing it through communicating with experts working in pharmaceutical companies, medical institutionsand other stakeholders.

  • Contribute to the health of patients around the world
  • Acquire the latest medical and pharmaceutical knowledge

Flow Workflow (as in of a Clinical Trial)

  • Step01

    • Feasibility study and selection of investigators/medical institutions
    • Clinical trial approval procedures at medical institutions (study sites)
    • Signing clinical trial agreements with medical institutions
    • Conducting study training to investigators and site staff
    • Confirming that study supplies (investigational new drugs, diagnostic kits,medical equipment, etc.) are available for implementing clinical trials

  • Step02

    • Discuss and negotiate with the principal investigator/sub-investigators concerning study enrollment
    • Monitoring

      Confirm informed consent status
      Confirm that clinical trials are conducted in compliance with laws, regulations, ministerial ordinances, protocol, etc.
      Confirm that diagnosis and treatment records (medical records) and all related records (source documents and data) are appropriately prepared and stored
      Confirm that all serious adverse events, etc. are appropriately reported
      Confirm that investigational new drugs, laboratory kits, equipment, etc. are stored appropriately and inventories and control records are appropriately prepared Confirm that all materials are stored by study sites, IRB (Institutional Review Board), principal investigators as appropriate
      Confirm that the contents in case report forms (paper CRF or EDC) are accurate and are created according to the correct procedure
      Confirm that the latest information pertaining to clinical trials is provided to the principal investigator in a timely manner
      ＊If any of the above is inappropriate, promptly hold discussions with the principal investigator and other stakeholders to ensure that corrective measures are implemented.

    • Confirm whether there are any changes at the study site triggering an amendment of the clinical trial notification
    • Confirm the progress in administrative procedures (IRB review of safety information, etc.) and other procedures pertaining to the clinical trials

  • Step03

    • Responding to data queries in case report forms (paper CRF or EDC) Clinical trial close-out procedures
  • We have various projects in clinical trials (industry-initiated clinical trials and investigator-initiated studies), clinical research, and PMS (post-marketing surveillance).
  • The duration of Step 01 to Step 03 may differ greatly according to the therapeutic area (from about 6 months to more than 8 years).
  • Since Clinical Research Associate need to visit medical institutions, the ratio of their work between on-site and off-site duties is roughly 50:50.

Primary Major Therapeutic Areas

  • Oncology
  • CNS (central nervous system)
  • Ophthalmology
  • Dermatology

Clinical Research Associate can engage in development of new drugs in various fields in addition to the above (regenerative medicine-related products, etc., medical devices, pharmacology, etc.).

Skill Required Knowledge and Skills

  • Medical and pharmaceutical knowledge
  • Communication skills
  • Schedule coordination skills
  • Adminstrative and data processing skills using a PC, etc.
  • English skills

Skill Knowledge and Skills gained on the job

  • Knowledge in ministerial ordinances (GCP, GPSP, etc.)
  • Knowledge in the latest drugs, medical devices, medical technologies, etc.
  • English skills

Career Paths Career Path Examples

  • Ms.A

    • Clinical Research Associate (3 years)
    • Clinical Research Associate (specialized in Oncology)

  • Mr.B

    • Clinical Research Associate (5 years)
    • CL/Clinical Leader to lead Clinical Research Associate (5 years)
    • Project Management (internal transfer)

  • Mr.C

    • Clinical Research Associate (5 years)
    • Pharmacovigilance (internal transfer)

Data Data

  • Academic background

    Science

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    Humanities

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  • New graduate to Mid-career Ratio

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  • Age composition

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    50s

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    over 60s

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As of March 31, 2024