Clinical Trial Assistant

Pace Hr Consulting; Chennai; Vor Ort; INR 450.000 - 650.000; Vollzeit

Zusammenfassung

Pace Hr Consulting is hiring for a Leading Clinical Research Organisation to appoint a Clinical Trial Assistant in Chennai. The role requires a minimum of 2 years of experience and supports multicentre trials from feasibility to close-out.

You will work with Project Managers, CRAs and cross-functional teams, maintaining TMF/eTMF and CTMS records, tracking deliverables across countries, and supporting site activation, monitoring, and audits, with travel as required.

Qualifikationen

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

Aufgaben

• Feasibility and site identification: identify investigators and sites; manage confidentiality agreements and feasibility questionnaires; compile findings.
• Study start up and site activation: gather essential documents; coordinate ethics submissions; track approvals and activations.
• Site coordination and trial support: assist CRAs and PMs with site communications, visits, materials, and minutes; maintain trackers across countries.
• Trial documentation and systems: maintain TMF/eTMF, ISF, CTMS; perform quality checks and manage versions and filing.
• Cross-functional coordination: liaise with Regulatory, Data Management, Medical Writing, Safety, Quality and vendors; track trainings and shipments.

Kenntnisse

ICH-GCP

Monitoring

Site management

Communication

Willing to travel

Tools

CTMS

TMF/eTMF

Jobbeschreibung

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 elevate 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.
• 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.

• 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; elevate quality, safety and compliance concerns promptly.

• 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.
• 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

• 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.