We are hiring for Leading Clinical Research Organisation

Role: Clinical Trial Assistant

Experience: min 2 Years

Reporting To: Head Project Management / Clinical Trial Lead

Location: Chennai

NOTE- Candidate should be willing to relocate Chennai

Role purpose

Support the delivery of global multicentre clinical trials from feasibility and study start-up through conduct and close-out. The Clinical Trial Assistant works with Project Managers, CRAs, investigators and cross-functional teams to coordinate site activities, maintain essential records and track deliverables across countries, in accordance with study requirements, applicable regulations and Company procedures.

Key responsibilities

- Feasibility and site identification: Identify and contact potential investigators and sites; coordinate confidentiality agreements and feasibility questionnaires; validate responses, patient availability, site capabilities and competing studies; consolidate findings and maintain investigator and site databases.
- Study start up and site activation: Collect and review essential documents for completeness; coordinate ethics committee and regulatory submission packages with the responsible teams; track approvals, site contracts, budgets, training and activation prerequisites; follow up on outstanding items and escalate delays.

• Site coordination and trial support: Support CRAs and Project Managers with site communication, visit scheduling, study materials, meeting minutes and action follow-up. Maintain recruitment, enrolment, visit and milestone trackers, and coordinate across countries and time zones.

• Trial documentation and systems: Maintain accurate and timely TMF/eTMF, investigator site file and CTMS records; perform assigned document quality checks; manage document versions,



filing and reconciliation; follow up on missing or expired records and support inspection readiness.

- Monitoring and data follow up: Support assigned in-house and remote monitoring activities under the study monitoring plan and appropriate supervision. Track data entry, queries, missing documents, protocol deviations and site action items; escalate quality, safety and compliance concerns promptly.

• Cross functional coordination: Coordinate with Regulatory, Data Management, Medical Writing, Safety, Quality and vendors on assigned deliverables. Track training, study supplies, shipments, invoices and investigator payments as delegated, and support site close-out and archiving.

- Quality and compliance: Follow the protocol, ICH-GCP, applicable country requirements and company SOPs. Protect participant confidentiality, maintain accurate records, support audits and corrective actions, and complete required training within agreed timelines.

Required skills and competencies

• Strong understanding of ICH-GCP and clinical trial regulations.

• Robust 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

• In-house monitoring experience or at least one year of experience as a Clinical Research Associate.

• 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 and clinical trial coordination roles.

Interested Candidates can share there CV at [email protected] or Whatsapp- (phone hidden)

Regards

Nupur Tathe

(HR Recruiter)

Pace HR Consulting LLP

📌 Clinical Trial Assistant (Chennai)
🏢 Pace Hr Consulting
📍 Chennai