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 & Competencies
As 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 & Tools
To 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.