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Job Id 221023
Title Sr Clinical Research Associate
Job Type Permanent
City Hyderabad
State Telangana
Job Description

Company Description

MakroCare | A MakroGroup Company
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

Job Description: Sr Clinical Research Associate (Sr CRA)
Job Overview:
  • Work under Clinical Research Managers/Principal Investigators, tasked with administering clinical trials.
  • Primary responsibilities include managing clinical trials and collecting data, Involve Audits, Documentation, informing participants about study objectives, and administering questionnaires.

  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Documentation of Audits and recording of information through computerized processes such as clinical trial management systems and electronic data capture.
  • Liaising with doctors/consultants or investigators on conducting the trial.
  • Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Source data verification.
  • Monitoring the trial throughout a specified duration involves monitoring visits to the trial sites.
  • Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted.
  • Writing visit reports, filing and collecting trial documentation and reports.

Eligibility Criteria:
  • Excellent communication skills (both written and oral)
  • Education must be in Life Sciences (B Pharmacy/M Pharmacy/Pharm D) only.
  • Experience should be 4 - 8 Years

Experience 4-8 Years
Job Category Clinical Operations
Posted On 11/19/2022
Expires On 12/19/2022
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