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Position: Clinical Research Scientist – I

Location: Navi Mumbai, Maharashtra, India

Job Description:

  • To ensure that the clinical study is conducted according to the approved protocol and applicable regulatory requirements.
  • To protect rights, safety, and welfare of subjects &Management of Investigational Products.
  • To ensure that a sufficient number of qualified medical, paramedical, and clerical staff is available to conduct the study.
  • To ensure that all staff assisting in the study are adequately trained on the protocol, investigational product, and their duties.
  • To be aware of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects.
  • To ensure that the data is complete, accurate, legible, and internally consistent and maintain timelines.
  • To take all study-related medical decisions.

  • To ensure that adequate medical care is provided to the subject for any adverse event, including clinically significant laboratory values.
  • In case of health-related problems, the investigator should inform the subject’s primary physician about the subject’s participation in the trial, if the subject has a primary physician and if the subject agrees to the primary physician being informed.
  • Review AE / SAE reporting forms after it is filled by the physician/designee.
  • To conduct a study in compliance with the protocol approved by IEC, sponsor, and regulatory agencies whenever applicable.
  • To ensure the accuracy, legibility, and completeness of data entry in the case record forms (CRFs) and in all other required report forms/logs as per the procedures and requirements.
  • To ensure that required documents are submitted to the IEC as per the procedure and requirement.
  • To ensure and maintain appropriate co-ordination with monitors, sponsors, and auditors.
  • To ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
  • Upon completion of the study, the investigator should provide a summary of the study outcome to the IEC, Sponsor, and Regulatory authority.

Qualification: MBBS/MD

Experience:  At least 4- 6 years of experience as a PI/CI in reputed BA/BE cente

Salary: Negotiable

Contact Details:

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