Clinical Research Associate – ( Freshers Only )

ClinoGenesis Research Institute; India; On-site; INR 300,000 - 420,000; Full time

Job summary

Clinogenesis Research Organization is seeking fresh graduates for a Clinical Research Associate (Trainee) role in Bengaluru. You will be mentored to develop proficiency in safety reporting, regulatory knowledge, audit readiness, and ethics documentation within Clinical Operations.

The program targets B.Pharm, M.Pharm, B.Sc, M.Sc (Life Sciences), or Nursing graduates, with training in EDC/CTMS systems and Microsoft Office. Freshers only.

Qualifications

• Understanding AE/SAE reporting and safety compliance.
• Familiarity with ICH-GCP guidelines and regulatory requirements (FDA/EMA).
• Ability to maintain audit-ready documentation and CRFs.

Responsibilities

• Assist in AE/SAE reporting workflows.
• Learn and apply ICH-GCP and regulatory standards.
• Support audit readiness and protocol adherence.
• Maintain Ethics Committee/IRB documentation and accurate CRF completion.

Skills

GCP knowledge

Regulatory knowledge

Audit readiness

Documentation

Ethics & compliance

Education

B.Pharm

M.Pharm

B.Sc (Life Sciences)

M.Sc (Life Sciences)

Nursing

Tools

Medidata Rave

Oracle CTMS

Microsoft Office

Job description

Clinical Research Associate (Freshers Only)

Organization: Clinogenesis Research Organization

Location: Bengaluru, Karnataka, India

Department: Clinical Operations

Type: Full-Time

Are you a recent Life Sciences or Pharmacy graduate looking to launch your career in Clinical Research? Clinogenesis is seeking passionate, entry-level talent to join our Clinical Operations team. This mentor-driven role is designed for candidates eager to build a foundation in professional clinical research.

Key Responsibilities & CompetenciesAs a Clinical Research Associate (Trainee), you will develop proficiency in the following industry-standard areas:Safety & Compliance: Understanding the lifecycle of Adverse Event (AE) and Serious Adverse Event (SAE) reporting.Regulatory Knowledge: Working according to ICH-GCP guidelines, as well as adherence to FDA, EMA, and local regulatory requirements.Audit Readiness: Learning the protocols necessary for maintaining audit and inspection readiness at all times.Ethics & Documentation: Applying Good Clinical Practice (GCP) to the Ethics Committee/IRB process, source document maintenance, and the accurate completion of Case Report Forms (CRFs).

Preferred Technical Skills & ToolsTo succeed in this role, candidates must demonstrate or be prepared to undergo rigorous training in the following tools and technical systems:Clinical Software: Proficiency or foundational knowledge in EDC systems (e.g., Medidata Rave, Oracle) and Clinical Trial Management Systems (CTMS).Documentation: Advanced competence in the Microsoft Office Suite for reporting and tracking.

Who Can Apply?Fresh graduates: B.Pharm, M.Pharm, B.Sc, M.Sc (Life Sciences), or Nursing.Note: This role is for Freshers only. Candidates with prior experience are not eligible.

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