Clinical Research Associate

Pace Hr Consulting; Chennai; On-site; INR 480,000 - 720,000; Full time

Job summary

Pace HR Consulting LLP is hiring a Clinical Research Associate for Chennai. The role requires at least 3 years of clinical research experience and willingness to relocate to Chennai. You will monitor sites, manage site relationships, ensure compliance with ICH-GCP, and support study execution across global teams.

The candidate will work under Head Project Management / Clinical Trial Lead, interacting with cross-functional teams and vendors to ensure inspection readiness and quality data.

Qualifications

• Minimum 3 years of experience in clinical research.
• Willing to relocate to Chennai.

Responsibilities

• Conduct Site Qualification, Initiation, Monitoring and Close-Out Visits (SQV, SIV, IMV, COV) for assigned activities.
• Perform source data review and verification (SDR/SDV) and assess protocol compliance, data quality and participant safety.
• Review essential documents and maintain inspection-ready site files.
• Prepare monitoring reports and follow-up communications within agreed timelines; track site issues and data queries through resolution.
• Support site activation, enrolment, retention and study close-out activities.

Skills

ICH-GCP

Site management

Monitoring

Communication

Stakeholder mgmt

Job description

We are hiring for Leading Clinical Research Organisation

Role: Clinical Research Associate

Experience: min 3 Years

Reporting To: Head Project Management / Clinical Trial Lead

Location: Chennai

NOTE- Candidate should be willing to relocate Chennai

Key Responsibilities

Clinical monitoring and site management

• Conduct Site Qualification, Initiation, Monitoring and Close-Out Visits (SQV, SIV, IMV, COV), independently for assigned activities following training and study authorisation.
• Perform source data review and verification (SDR/SDV) and assess protocol compliance, data quality and participant safety.
• Review essential documents and maintain inspection-ready site files.
• Prepare accurate monitoring reports and follow-up communications within agreed timelines; track site issues, protocol deviations and data queries through resolution.

Site performance and study execution

• Support site activation, enrolment, retention and study close-out activities.
• Monitor site performance and support enrolment improvement initiatives.
• Identify and identify operational risks and site-related challenges.

Investigator and stakeholder management

• Build and maintain strong relationships with investigators and site personnel.
• Serve as the primary operational contact for assigned sites.
• Participate in investigator meetings, study team meetings and site training.

Cross functional collaboration and compliance

• Collaborate with Clinical Operations, Data Management, Safety, Regulatory, Medical Writing and external vendors.
• Ensure compliance with ICH-GCP, protocol requirements and applicable regulations.
• Support sponsor audits, inspections and inspection-readiness activities

Skills and competencies

• Strong understanding of ICH-GCP and clinical trial regulations.
• Strong monitoring, site management and investigator relationship management skills
• Effective communication, stakeholder management and problem-solving abilities.
• Ability to work independently and within cross-functional global teams.
• Willingness to travel as required

Preferred experience

• Experience in global Phase II and Phase III clinical trials.
• Exposure to sponsor audits, inspections and co-monitoring visits.
• Demonstrated potential to progress into CRA II and Senior CRA roles.

Regards

Nupur Tathe

(HR Recruiter)

Pace HR Consulting LLP