Clinical Trial Associate (CTA)

Why This Role Matters
Clinical Trial Associates (CTAs) play a foundational role in ensuring clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards. They manage essential documentation, maintain Trial Master Files (TMF), and support Clinical Trial Leads (CTLs) and Clinical Research Associates (CRAs) in operational execution.
For B.Pharm and M.Pharm freshers, this position offers a structured entry into the clinical research industry, providing hands-on exposure to documentation control, CRF tracking, and regulatory compliance aligned with ICH-GCP guidelines.

Job Description
Biosphere Clinical Research Pvt Ltd is hiring Clinical Trial Associates (CTA) across India. This role is designed for freshers looking to build a career in clinical research, clinical documentation, and clinical operations.
As a CTA, you will support clinical teams in maintaining accurate documentation, tracking case report forms (CRFs), coordinating communications, and ensuring compliance with Standard Operating Procedures (SOPs) and regulatory requirements. The position offers practical exposure to real-time clinical trial management processes.

Key Responsibilities

Core Duties:
• Assist CTLs and CRAs in updating clinical tracking systems
• Maintain site compliance and performance documentation
• Prepare, distribute, and archive clinical trial documents
• Review study files for completeness and regulatory accuracy
• Track and manage CRFs and query resolution
• Maintain clinical data flow documentation
• Coordinate project communications and manage correspondence
• Support preparation and tracking of clinical trial supplies
• Ensure documentation compliance with SOPs and ICH-GCP guidelines
• Maintain audit-ready Trial Master Files (TMF)
• Ensure assigned tasks are completed within timelines
This role is critical in ensuring operational efficiency and regulatory readiness during audits and inspections.

Eligibility Criteria

Educational Qualification:
• B.Pharm
• M.Pharm

Experience:
• Freshers can apply
• Basic understanding of clinical research processes is preferred

Required Skills

• Clinical documentation handling
• CRF tracking and query management
• Proficiency in MS Office applications
• Data tracking and file management
• Strong written and verbal communication skills
• Time management and organizational skills
• High attention to detail
• Compliance awareness (ICH-GCP knowledge preferred)

Salary & Benefits

Estimated Salary Range: ₹2 – ₹4 LPA (based on skills and evaluation)
Additional Benefits:
• Entry-level opportunity in the clinical research industry
• Exposure to clinical operations and regulatory documentation
• Structured learning environment
• Career pathway toward CRA, Clinical Data Manager, or Regulatory Affairs roles
• Hands-on experience in documentation and compliance-driven operations

Company Overview
Biosphere Clinical Research Pvt Ltd operates within the clinical research and trial management domain in India. The organization focuses on maintaining regulatory standards, quality documentation, and smooth operational processes across clinical studies.
The company offers growth-oriented roles for pharmacy graduates aiming to establish long-term careers in clinical research operations.

FAQs

Q: Is prior experience required for this CTA role?
No. Freshers with B.Pharm or M.Pharm qualifications can apply.

Q: Is knowledge of ICH-GCP mandatory?
It is not mandatory but having a basic understanding will be an advantage.

Q: What career growth opportunities are available?
With experience, candidates can progress toward CRA, Clinical Data Management, Regulatory Affairs, or Clinical Operations roles.

Q: Is this role documentation-focused?
Yes. The position primarily involves clinical documentation management, CRF tracking, and regulatory compliance support.

Application Tips

• Highlight internships, academic projects, or coursework related to clinical research
• Mention familiarity with ICH-GCP or SOP-based environments
• Demonstrate attention to detail and documentation accuracy
• Prepare to discuss MS Office proficiency and data handling skills
• Emphasize time management and ability to meet deadlines