Veeda CR Hiring For Clinical Trial Assistant

Responsibilities

• Retrieve and organize ethics committee (EC) documents from central drive, print and prepare files for dispatch.
• Dispatch EC documents to respective trial sites before EC meetings.
• Coordinate with Clinical Research Department (CRD) to assemble Site Initiation Visit (SIV) kits.
• Include study-specific materials such as NS bottles, syringes, needles, digital clocks, thermo‑hygrometers, data loggers, and infusion pumps in SIV kits.
• Ship SIV kits to trial sites ensuring timely delivery prior to site initiation.
• Arrange investigational medicinal product (IMP) shipments to sites, liaising with pharmacy team and logistics vendors.
• Verify temperature control and documentation for IMP shipments.
• Coordinate pharmacokinetic (PK) blood sample shipments to the bio‑analytical laboratory.
• Manage logistics for patient sample collection, including courier scheduling and chain‑of‑custody documentation.
• Draft site invoices based on patient enrollment and study milestones.
• Follow up with sites for signed invoices and obtain necessary internal approvals (PM, HOD, COO).
• Submit approved invoices to finance for timely payment processing.
• Organize travel itineraries, tickets, advances, and hotel accommodations for phlebotomists.
• Communicate travel plans to sites and ensure phlebotomist availability for sample collection.
• Update Management Information System (MIS) with project start‑up, recruitment, and close‑out metrics.
• Reconcile revenue reorganization data received from project managers and share with finance.
• Maintain payment trackers for each site, monitoring outstanding balances and due dates.
• Track instrument and equipment usage per project and update inventory logs.
• Archive central investigator files, case report forms, and data management documents post‑study.
• Ensure compliance with GCP and regulatory requirements during document archiving.
• Process monitor (CRA) travel expenses, obtain signatures, and submit to finance.
• Prepare and circulate meeting minutes for internal and site meetings.
• Conduct regular status calls with site coordinators to address operational issues.
• Assist in preparing regulatory submissions such as IND, NDA, and safety reports as needed.
• Support the preparation of monitoring visit reports and corrective action plans.
• Maintain a master tracker for study timelines, milestones, and deliverables.
• Perform gap analysis on site documentation and recommend corrective actions.
• Coordinate with external vendors for equipment calibration and maintenance.
• Ensure all study supplies are stocked and reorder as required.
• Provide ad‑hoc support to senior clinical research associates and project managers.

Skills

• Clinical trial coordination
• Ethics Committee (EC) submission management
• Site Initiation Visit (SIV) kit preparation
• Investigational Medicinal Product (IMP) logistics
• Pharmacokinetic (PK) sample handling
• Good Clinical Practice (GCP) compliance
• Regulatory documentation
• Vendor management
• Invoice drafting and financial reconciliation
• MIS data entry and reporting
• Tracker maintenance
• Document archiving
• Travel expense processing
• Phlebotomist scheduling
• Communication and stakeholder management
• Time‑line tracking
• Problem‑solving and issue resolution
• Attention to detail
• Knowledge of ICH guidelines
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Experience with clinical trial management systems (CTMS)
• Ability to work under tight deadlines
• Team collaboration
• Data integrity assurance
• Sample chain‑of‑custody procedures
• Inventory management
• Risk assessment
• Reporting to senior management
• Adaptability in fast‑paced environments
• Basic understanding of pharmacology and drug development

Company Overview

Veeda CR is a leading contract research organization (CRO) based in Ahmedabad, specializing in end‑to‑end clinical trial services for pharmaceutical and biotechnology companies. With a robust portfolio that includes Phase I to Phase IV studies, Veeda CR delivers high‑quality data through expert clinical operations, regulatory affairs, pharmacovigilance, and data management. The company boasts a strong market presence across India and the Middle East, leveraging state‑of‑the‑art laboratories, a dedicated network of trial sites, and a compliance‑driven culture. Career growth at Veeda CR is accelerated by continuous learning programs, mentorship from senior scientists, and exposure to global therapeutic areas, making it an attractive destination for fresh talent and experienced professionals seeking to advance in the life‑sciences industry.

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