Job Id
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221023
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Title
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Sr Clinical Research Associate
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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Job Description
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Company DescriptionMakroCare 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.
Responsibilities: - 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
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Qualification
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Certification/Licensure
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Experience
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4-8 Years
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Job Category
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Clinical Operations
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Posted On
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11/19/2022
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Expires On
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12/19/2022
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