B Pharma Project Coordinator Post Vacancy @ Intas

B Pharma Project Coordinator Post Vacancy @ Intas

 Pharma Project Coordinator  Post Vacancy @ Intas. B Pharma jobs at Intas. Intas hiring Pharma candidates for the post of Quality Control. Project Coordinator post vacancy at Intas. Intas Pharmaceutical Limited invites undergraduates Pharma candidates for Project Coordinator post vacancy. Candidates with experience in Pharma filed may apply for this job post via online mode. Check out all the details on the same below:

Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly

Job Title: Project Coordinator

Location – Ahmedabad, Mehsana

Eligibility: B.Pharma – Pharmacy

Salary: INR 3,00,000 – 5,00,000 P.A. Medical Insurance (self + 3 Family Member)

Job Description:

  • Ensure project coordination and conduct as per protocol and SOPs
  • Work in close coordination with the Principal Investigator and Head-CPMA
    Pre-study:
  • Review and finalization of protocol, ICF, CRF and other appendices (applicable in case of special studies)
  • Communicate with sponsor on all projects related issues.
  • Distribute protocol and related documents.
  • Handle project related IP and its documentation (IP retrieval, verification, accountability, dispensing etc).
  • Issuance of SOP related forms
  • Prepare labels and Binders (binder, files, dispensing labels etc).
  • Verification of Randomization schedule
  • Train the study personnel on project related activities and hand over relevant documents to concerned person.
  • Ensure arrangement of staff and other study related activities.
    Ensure proper initiation and conduct of the trial.
    During study:
  • Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies
  • Ensure proper documentation of Adverse Drug Reactions, Note to files, Deviations etc.
  • Reporting of SAEs as per regulatory requirements
  • Accountability of ICF and Criteria checks
  • Check all forms including consent forms.
  • Ensure arrangement for activities like, ambulatory, precheck-in visits, post study and co-ordination of the same.
  • Co-ordinate QA audits of corrected forms.
  • Ensure subject contact during the washout period and follow-ups

    Post-study:

  • Handle subject compensation.
  • Check all the forms
  • Generate protocol deviations
  • Send clinical updates to all concerned.
  • Send communications of discontinued subjects, BA details to concern.
    Others:
  • Take part in the day-to-day clinic activities
  • Help maintain and update all the systems and SOPs in the department
  • Train the staff on the entire Project related aspects and related SOPs & giving inputs for developing systems.

Apply Online

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