Job Description
Assists the Study Coordinator in executing jobs assigned for conducting a clinical study in compliance with SOPs/Protocol.
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centres Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection
Assists with follow-up appointments of Subjects
Assists as required in the receipt, dispensation and inventory of test materials
Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screening/clinic activities
Ensures clinic staff activities for compliance with protocol and SOPs
Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report
Assist with the distribution of test articles to subjects as delegated by the Study Coordinator
Conducts activities related to the transfer of subject samples
Responsible for initiation and completion of archival of clinic study raw data, documents and records.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: INR 2,50,000 - 5,00,000 P.A. Best In The Industry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills: Clinical Operations, Clinical Trails, BE / BA Studies, Clinical Research Coordinator, CRC, CRO
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centres Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection
Assists with follow-up appointments of Subjects
Assists as required in the receipt, dispensation and inventory of test materials
Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screening/clinic activities
Ensures clinic staff activities for compliance with protocol and SOPs
Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report
Assist with the distribution of test articles to subjects as delegated by the Study Coordinator
Conducts activities related to the transfer of subject samples
Responsible for initiation and completion of archival of clinic study raw data, documents and records.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: INR 2,50,000 - 5,00,000 P.A. Best In The Industry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills: Clinical Operations, Clinical Trails, BE / BA Studies, Clinical Research Coordinator, CRC, CRO
Desired Profile
Qualified M. Pharm - Pharmacolgy candidate is preferredShould be well versed with clinical trails and trial process monitoring.
Should have exposure to regulatory guidelines with respect to clinical operations.
Should be good in verbal and written communication skills.
Should be flexible to work in shifts.
Education:UG -B.Pharma - Pharmacy, Pharmacy, Pharmacy
PG - M.Pharma - Pharmacy, Pharmacy, Pharmacy
Doctorate - Any Doctorate - Any Specialization, Any Specialization, Any Specialization, Doctorate Not Required
Should have exposure to regulatory guidelines with respect to clinical operations.
Should be good in verbal and written communication skills.
Should be flexible to work in shifts.
Education:UG -B.Pharma - Pharmacy, Pharmacy, Pharmacy
PG - M.Pharma - Pharmacy, Pharmacy, Pharmacy
Doctorate - Any Doctorate - Any Specialization, Any Specialization, Any Specialization, Doctorate Not Required
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