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SMOConnect Clinical Research Services Pvt Ltd
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Project Executive Trainee - Clinical Trial Operations

Project Executive Trainee - Clinical Trial Operations

SMOConnect Clinical Research Services Pvt Ltd

0 years

0 Lacs

cochin

Posted:3 weeks ago| Platform: GlassDoor logo

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Skills Required

planning ethics compliance gcp support qc training certifications management initiation enrollment scheduling monitoring maintenance finance report data verification

Work Mode

On-site

Job Type

Full Time

Job Description

1. Project Planning & Support

Assist in developing project plans, timelines, and trackers under guidance of Project Manager (PM).
Help in preparing project

2. Regulatory & Ethics Compliance

assist with submission packages to Ethics Committees
Maintain and track approvals, amendments, and correspondence.
Ensure compliance with ICH-GCP, SOPs, and local regulations.
Follow up EC meeting and EC approvals
Support collection and QC of essential documents (CVs, medical licenses, GCP training certificates, lab certifications, insurance)

3. Site Management Coordination

Coordinate with site teams for collection of essential documents.
Track site readiness, initiation status, and enrollment progress.
Support CRAs in scheduling monitoring visits (SIV, IMV, COV).
Ensure proper maintenance of Investigator Site Files (ISFs)

4. Cross-functional Coordination

Work closely with CRAs, CTAs, Regulatory, and Finance teams.
Report to the Project Manager and Senior Project Exceutive
Coordinate investigator meetings, training sessions, and study calls.
Assist in preparing meeting agendas, presentations, and minutes.

5. Data & Documentation

Check document completeness and quality control.
Assist with data entry and verification in project management systems

Job Types: Full-time, Permanent, Fresher

Pay: From ₹5,000.00 per month

Work Location: In person

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