Clinical Research Associate

JSS Medical Research, Inc.; Hyderabad, Pune District, Delhi; Hybrid; INR 600,000 - 900,000; Full time

Job summary

JSS Medical Research, Inc. seeks an experienced CRA to oversee onsite monitoring, site qualification, and investigator engagement for clinical studies. You will coordinate with investigators, ensure regulatory submissions, and support audit readiness.

The role requires 2-3 years of CRA experience, postgraduate education in lifesciences or related fields, and proficiency in MS Office. Significant travel (50-70%) is anticipated, with on-site work at study sites.

Qualifications

• 2-3 years of CRA onsite monitoring experience required.
• Postgraduate degree in lifesciences/science or equivalent.
• Proficient in MS Office and data recording.
• Solid knowledge of Good Clinical Practices and documentation.

Responsibilities

• Site selection and qualification.
• Meet with investigators and staff; train site team as needed.
• Ensure EC dossier submission, approvals, and site initiation.
• Monitor recruitment and study progress per protocol and regulations.
• Perform site and/or remote monitoring of source documents, CRFs, and related records.
• Identify and mitigate bottlenecks at sites to ensure timelines.
• Ensure data collection and return of study materials to sponsor.
• Prepare sites for audits/inspections.
• Maintain archival inventory of source documents and CTMs.
• Travel 50-70% of the time.

Skills

CRA onsite monitoring

MS Office

Good Clinical Practices

Good Documentation Practices

Education

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

Job description

Roles and Responsibilities

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

2-3 Years experience as CRA with onsite monitoring is must.

• 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
• 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