Clinical Research Associate

JSS Medical Research; Pune District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

JSS Medical Research in Pune, India is seeking a Clinical Research Associate to conduct site monitoring, ensure GCP compliance and drive study progress across sites.

The role requires 2-3 years of CRA experience, postgraduate qualification, proficiency in MS Office, and willingness to travel 50-70%. You will coordinate with investigators and manage site activities.

Qualifications

• 2-3+ years experience as CRA with onsite monitoring (minimum).
• Postgraduate qualification in lifesciences or related field.
• Proficient in MS Office and GCP/GDP practices.

Responsibilities

• Site selection and qualification.
• Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, if required train the study site team.
• Ensures EC dossier submission at sites, approval and site initiation visit (Remote / On site).
• Ensuring targeted recruitment.
• Monitor study progress to assure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practices.
• Monitor and track patient enrollment and study progress.
• Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder, CTM & NCTM accountability, other documents as applicable
• Identify and mitigate bottlenecks at sites.
• Ensure collection of all data and remaining study supplies for return to the Sponsor/JSS.
• Prepare the site for possible Internal and/or Client Audits / Inspections.
• Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site
• RSCOV / SCOV
• This position requires 50-70% travel

Skills

Good Clinical Practices

Education

Postgraduate Lifesciences/Science/BDS/MDS/BAMS, BHMS

Tools

MS Office

Job description

Roles and Responsibilities

Essential Functions: The following duties represent the principle job duties however they are not all inclusive:

• Site selection and qualification
• Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, if required train the study site team
• Ensures EC dossier submission at sites, approval and site initiation visit (Remote / On site)
• Ensuring targeted recruitment
• Monitor study progress to assure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practices
• Monitor and track patient enrollment and study progress
• Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder, CTM & NCTM accountability, other documents as applicable
• Identify and mitigate bottlenecks at sites
• Ensure collection of all data and remaining study supplies for return to the Sponsor/JSS
• Prepare the site for possible Internal and/or Client Audits / Inspections
• Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site
• RSCOV / SCOV
• This position requires 50-70% travel

Skills and Qualifications

• Minimum 2-3 Years experience as CRA with onsite monitoring is must.
• Postgraduate- Lifesciences/Science/BDS/MDS/BAMS, BHMS
• MS Office
• Requirements of Good Clinical Practices
• Requirements of Good Documentation Practices