B Pharma Project Coordinator Post Available @ Intas

B Pharma Project Coordinator Post Available @ Intas

B Pharma jobs. Pharma jobs. Intas hiring candidates with a bachelors degree in Pharmacy.Project Coordinator Post vacant @ Intas.Intas 2019 Jobs, Intas Project Coordinator jobs, Pharmaceutical Science jobs  2019. Intas hiring B Pharma candidates for a Project Coordinator Post. Interested and eligible candidate can Apply for this post.Check out all the details about the job below:

Job Title: Project Coordinator

Work Location: Ahmedabad

Eligibility: UG -B.Pharma – Pharmacy

Salary: INR 3,00,000 – 5,00,000 P.A.

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.
• 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

Key Skills:

• 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.

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