We are looking for a detail-oriented and organized Clinical Trial Assistant (CTA) to support clinical research operations and ensure smooth execution of clinical trials in compliance with regulatory guidelines and study protocols.
Key Responsibilities:
- Assist in the planning, coordination, and execution of clinical trials from initiation to close-out.
- Support Clinical Research Associates (CRAs) and Clinical Trial Managers in day-to-day study activities.
- Maintain and manage Trial Master Files (TMF) and ensure proper documentation as per regulatory requirements.
- Track study timelines, site progress, and data collection activities.
- Coordinate with clinical sites, investigators, and vendors to ensure smooth study operations.
- Assist in preparation and review of study-related documents including protocols, reports, and regulatory submissions.
- Ensure compliance with ICH-GCP guidelines and applicable regulatory standards.
- Support audit and inspection readiness activities.
- Manage study supplies, tracking logs, and communication records.
Required Skills & Qualifications:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- 0–3 years of experience in clinical research or clinical trials (freshers with internship experience may apply).
- Basic understanding of clinical trial processes and ICH-GCP guidelines.
- Strong documentation and organizational skills.
- Good communication and coordination abilities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Preferred Skills:
- Experience with TMF management systems or clinical trial software.
- Exposure to regulatory submissions or clinical documentation handling.
- Ability to work in a fast-paced, detail-driven environment.