Clinical Trial Coordinator at Ahmedabad for Pharma

1 week ago


Ahmedabad, Gujarat, India People Alliance Human Resource Development Foundation Full time
Clinical Trial Coordinator - Mumbai for Pharma Company

Qualification:

  • A postgraduate in life sciences/PharmD
  • GCP trained and Certified

Required Skills:

  • Thorough understanding of drug development process and expertise in NDCT rules & ICH-GCP/Indian GCP
  • Knowledge of clinical trial regulation of US FDA, EMEA, NDCT rules, ICMR guidelines.
  • Good leadership qualities and skills.
  • Ability to communicate properly between the physician, patient & the site head.
  • Assist the Site Head in the managing the Site to ensure ethical conduct of research activities.
  • Assist Site Head in evaluates protocols, policies and procedures regarding research projects and studies.
  • Maintains pertinent records and documentation.
  • Maintenance of Investigator Master File as per good documentation practices & SOP including generation of source documents.
  • Oversight of Site Initiation Visit, Monitoring Visits, Site Closeout Visit.
  • CRF, eCRF entry, Data Query resolution.
  • Assist the pharmacist in drug accountability and temperature maintaining logs.
  • Endow the required file notes, weekly and monthly and monthly report to the reporting authority.
  • Tracking the status of all study activities.
  • Report to the Site Head daily and take advice for further action.
  • Responsible for the Ethics committee activities.
  • Coordination of Clinical trial archival documents.
  • Coordination Preaudit, Audit, Post Audit preparation for NABH accreditation.

Salary:
Up to ₹400,000.00 per year

Benefits:

  • Cell phone reimbursement

Schedule:

  • Day shift

Supplemental pay types:

  • Commission pay
  • Performance bonus

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