Research Associate

Lupin; Pune District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Lupin in Pune Province, India, is seeking professionals for quality assurance in clinical studies. The role focuses on QC checks of study data, ensuring adherence to GCP, SOPs, and protocols, and monitoring in-process activities.

The candidate will participate in system audits of the clinical facility as per internal SOPs. Applicants with a Masters and a Graduation in Pharmacy, and 0-3 years of related experience are preferred.

Qualifications

• Experience ensuring data integrity in clinical studies.
• Familiarity with GCP, protocols, SOPs and applicable guidelines.
• Experience in audits of clinical facilities or systems.

Responsibilities

• Perform QC checks of study-related source data (Reg forms, ICFs, Trial Master File, CRFs).
• Compile and submit study data to QA within set timelines.
• Ensure activities comply with GCP, protocol and SOPs during study conduction.
• Monitor in-process activities like dosing, sample collection/processing/segregation; Audit systems per SOPs.

Skills

Quality control

GCP compliance

Monitoring activities

Audit process

Education

Masters

Bachelors in Pharmacy

Job description

• To Perform Quality Control check of all study related source data (Registration Forms,Informed Consent Documents, Trial Master File, General Case Record Documents, Logbooks and Subject CRFs etc) compilation and submission of study related data to QA department within set timelines.
• To ensure all the activities / processes are performed as per GCP, Protocol, SOP and applicable guidelines during study conduction.
• To Perform monitoring of in process actitivties like Dosing, Sample collection, Sample Processing , sample segregation etc.
• To perform system audit of clinical facility as per inhouse SOP.

Work Experience

0-3 years

Education

Masters

Graduation in Pharmacy

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