Clinical Trial Assistant

Evoke HR Solutions Pvt. Ltd.; Ahmedabad District; On-site; INR 300,000 - 420,000; Full time

Job summary

Evoke HR Solutions Pvt. Ltd. is seeking a Clinical Trial Assistant to support planning, coordination, and execution of clinical studies. The role involves trial documentation, regulatory submissions, and maintaining trial records in line with GCP guidelines.

Ideal candidates hold a relevant degree and are eager to learn about regulatory processes; freshers are welcome. Full-time position based in Ahmedabad district, Gujarat.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related disciplines.
• Freshers welcome to apply.
• Basic understanding of clinical trials and processes.
• Knowledge of medical terminology and trial documentation.

Responsibilities

• Assist clinical research teams in coordinating and managing trial activities.
• Prepare, organize, and maintain essential clinical trial documents.
• Support TMF and ISF maintenance.
• Assist in preparing protocols, informed consent forms, and study docs.
• Track trial progress, timelines, and milestones.
• Coordinate with CRAs, investigators, sponsors, and teams.
• Support regulatory document collection, review, and submissions.
• Maintain accurate records of trial activities and correspondence.

Skills

Clinical trial coordination

Regulatory documentation

TMF & ISF knowledge

ICH-GCP understanding

Education

B.Pharm / M.Pharm / Pharm.D

Life Sciences / Biotechnology

Job description

Job Title: Clinical Trial Assistant
Department: Pharmaceutical & Biotechnology
Role: Clinical Research Scientist
Experience: 01 Year (Freshers Can Apply)
Job Type: Full-Time

About the Role

We are looking for a detail-oriented and organized Clinical Trial Assistant to support the planning, coordination, and execution of clinical research studies. The candidate will assist clinical research teams with trial documentation, regulatory submissions, study coordination, and maintenance of clinical trial records. The role involves ensuring that clinical studies are conducted efficiently while following applicable regulatory guidelines, study protocols, and Good Clinical Practice (GCP) standards.

Key Responsibilities

• Assist clinical research teams in coordinating and managing clinical trial activities.
• Prepare, organize, and maintain essential clinical trial documents.
• Support the maintenance of Trial Master Files (TMF) and Investigator Site Files (ISF).
• Assist in preparing clinical trial protocols, informed consent forms, and study-related documentation.
• Track clinical trial progress, timelines, and study milestones.
• Coordinate with Clinical Research Associates (CRAs), investigators, sponsors, and research teams.
• Support regulatory document collection, review, and submission processes.
• Maintain accurate records of clinical trial activities and study correspondence.

Eligibility

• Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm), Pharm.D, Life Sciences, Biotechnology, Microbiology, Nursing, or related disciplines.
• Freshers interested in clinical research and clinical trial management are encouraged to apply.
• Basic understanding of clinical trials and clinical research processes.
• Knowledge of medical terminology and clinical trial documentation.

Required Skills

• Clinical trial coordination and administration.
• Clinical research documentation.
• Knowledge of Trial Master Files (TMF) and Investigator Site Files (ISF).
• Understanding of ICH-GCP guidelines.
• Regulatory documentation and record management.