Clinical Trial Assistant (CTA)

ClinoGenesis Research Institute; Mumbai; On-site; INR 279,000 - 390,600; Full time

Job summary

A clinical research organization in Mumbai is seeking a Clinical Trial Assistant to support clinical operations. The role involves maintaining trial documentation, tracking study progress, and assisting with regulatory submissions. The ideal candidate has a background in life sciences, strong organizational abilities, and familiarity with clinical research terminology. This is a full-time entry-level position offering valuable experience in clinical trials.

Qualifications

• Basic understanding of clinical research and medical terminology.
• Familiarity with ICH-GCP guidelines preferred.
• Ability to organize and maintain documentation.

Responsibilities

• Update Trial Master File and study documentation.
• Prepare and distribute study-related documents.
• Track clinical supplies and subject enrollment.
• Schedule trial meetings and monitor visits.
• Assist with regulatory submissions and ethics approvals.

Skills

Understanding of clinical research

Knowledge of medical terminology

Organizational abilities

Communication skills

Proficiency in MS Office

Education

BSc/MSc Life Sciences

Biotechnology

Microbiology

Pharmacy (B.Pharm / M.Pharm / Pharm.D)

Nursing (BSc Nursing)

Biomedical Science

Medical Laboratory Technology (MLT)

Public Health

Allied Health / Biological / Health Sciences

Job description

Job Title: Clinical Trial Assistant (CTA)

Company: Clinogenesis Research Organisation

Department: Clinical Operations

Level: Entry-Level / Fresher

Job Summary

At Clinogenesis Research Organisation, the Clinical Trial Assistant (CTA) will support clinical operations and contribute to the successful execution of clinical studies. This role involves assisting with documentation, site coordination, communication, and study tracking to ensure compliance with regulatory and study requirements.

Key Responsibilities

• Maintain and update Trial Master File (TMF/eTMF) and study documentation.
• Assist in preparation, review, and distribution of study‑related documents (ICFs, logs, reports, etc.).
• Track clinical supplies, site progress, and subject enrollment.
• Support the scheduling of clinical trial meetings, monitoring visits, and training sessions.
• Assist with regulatory submissions, ethics approvals, and version tracking.
• Maintain trackers, spreadsheets, and study logs efficiently and accurately.
• Perform data entry and ensure completeness and accuracy of study information.
• Coordinate communication between clinical sites, vendors, and internal teams.
• Support safety reporting and documentation as per guidelines.

Eligibility Criteria

• BSc/MSc Life Sciences
• Biotechnology
• Microbiology
• Pharmacy (B.Pharm / M.Pharm / Pharm.D)
• Nursing (BSc Nursing)
• Biomedical Science
• Medical Laboratory Technology (MLT)
• Public Health
• Allied Health / Biological / Health Sciences

Skills Required

• Basic understanding of clinical research and medical terminology.
• Familiarity with ICH‑GCP guidelines (training or certification preferred).
• Strong organizational and documentation abilities.
• Effective communication and interpersonal skills.
• Proficiency in MS Office (Word, Excel, PowerPoint).

Seniority level: Entry level

Employment type: Full-time

Job function: Research, Analyst, and Information Technology

Industries: Education