Scientist/Senior Associates -BioAnalytical
Qualifications: PhD in Analytical Chemistry with 3-5 Years of Experience. Or M Sc - AnalyticalChemistry / M Pharm in Pharmaceutical Analysis with 4-8 Years.
Skillsets:
- Knowledge of Implementation of GLP and Regulatory Guidelines
- Sound knowledge in Method Development and Validation on LC-MS/MS and HPLC.
- Knowledge in preparing and reviewing SOP's.
- Should be able to analyse the analytical and audit reports.
- Should be able to review chromotograms during the study sample analysis.
Principal Investigators
Qualifications: MBBS and MD Pharmacology with 1-2 Years of Experience as as ClinicalPharmacologist.
Skillsets:
- Thorough knowledge of ICH-GCP and Regulatory Guidelines.
- IEC/IRB affairs..
- Protocol, CRF and ICF preparation.
- Subject Enrolment.
- Informed Consent Process and Documentation.
- Adverse Event recognition, management and reporting
- Managing Regulatory audits.
- SOP preparation and review
Clinical Investigators
Qualifications: MBBS with 2-4 Years of ICU Experience
Skillsets:
- Volunteer Screening and Selection
- Subject monitoring during the study
- Adverse event reporting
- Emergency support/subject safety
- Incharge of ICU
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