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Job Opening details:-
Company Name :- Lobo Staffing Solutions
Position Name :- Clinical research
Company Location :- Mumbai, Maharashtra
Job Category : General Category
Full Job Description :-
Position – Cinical research
Salary-500000 CTC
Location – Vikroli
Qulification – Pharmacy
Gender – male.
➢ To handle BA/BE studies in Healthy Human Volunteers, as a
Associate Project Co-ordinator as per protocol and SOPs.
➢ To monitor the clinical Study of BA/BE studies in compliance with ICH GCP, SOP, Regulatory Guideline.
➢ Preparation of Standard Operating Procedure and conducting training
for the same.
➢ ICD presentation and obtaining to the volunteer.
➢ Prepare, Review and compile all the study related documents (CRF and
source documents) to ensure the completeness, correctness and
compliance to the protocol.
➢ Prepare Clinical Study Report, Study Summary Report and Study
updates.
➢ Reporting of AE(s)/SAE(s) to ethics committee.
➢ Resolution of facility/study related QA/QC findings.
➢ Work in coordination with the Principal Investigator for Review and
finalization of Protocol, ICF & other appendices (applicable in case of
special studies)
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