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Clinical Research Assoc II

4.00 to 6.00 Years   Navi Mumbai   26 Feb, 2020
Watson Pharma Private Limited
Job LocationNavi Mumbai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaAllied Health ServicesSales / BD
EmploymentTypeFull-time

Job Description

  • Ensuring clinical study activities like informed consent process breathe alcohol, Drug of Abuse, check - in, check out, protocol restrictions, standardized meals, follow ups, compilation of documents were performed as per SOP and protocol.
  • Intimation of Adverse events encountered to Clinical Investigator/ Principle Investigator /Study Physician.
  • Administration & Supervision of IPs to study subjects.
  • Reviewing of study related documents and study binders for completeness.
  • Monitoring of the subjects during clinical confinement.
  • Ensuring general information to subject for registration, screening and respective study were provided.
  • Performing & Ensuring plasma separation, storage, segregation & transfer to bioanalytical department is done as per SOP and protocol.
  • Preparation and checking of labels for vacutainers, plasma separation vials, segregation and medication for pivotal, pilot and blank plasma study.
  • Preparation and checking of tables (OGD) of pivotal study and assist in pilot study.
  • Preparation and coordination in pre, during and post study activities.
  • Implement and ensure all the activities were performed in compliance with SOPs and Protocol.
  • Ensure that staffs are trained on SOPs, revised SOPs and protocol before performing activities.
  • Ensure sufficient, qualified, trained and experienced staffs are available to perform the activities.
  • Ensure all the instruments are calibrated as per the calibration schedule.
  • Coordinating with Pathology Lab., QA department, statistician, accounts department and other concerned departments for smooth and planned execution of clinical studies or as per need.
  • Ensure proper handling and maintenance of logbooks.
  • Any other duty assigned by the Principal Investigator/ Head of department.
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Keyskills :
music makingadverse events informed consentclinical research clinical study gnmips

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