Clinical Research Trainer

Key Responsibilities:

1.Training & Curriculum Development:

Develop and deliver a structured training program in Clinical Research.

Cover essential topics like clinical trial phases, ICH-GCP guidelines, ethics, regulatory submissions, pharmacovigilance, and medical writing.

Prepare study materials, case studies, assignments, assessments and student's projects.

Conduct live sessions, workshops, webinars and interactive discussions.

Provide Hands-On training on tools/softwares used in CR.

Stay updated with the latest clinical research regulations, drug approvals, and trial methodologies.

2.Student Engagement & Mentorship:

Guide students on career opportunities in Clinical Research.

Conduct Q&A sessions, real-world case studies, and practical exercises.

Provide insights into clinical data management, biostatistics, and trial monitoring.

Provide project work related guidance to students on Clinical Research.

3.Industry Compliance & Collaboration:

Ensure the training aligns with ICH-GCP, CDSCO, US FDA, and EMA regulations.

Collaborate with industry experts to bring real-world insights into the course.

4.Assessment & Feedback:

Evaluate student performance through quizzes, assignments, projects, and mock tests.

Gather continuous feedback to improve training quality.

Qualifications & Experience:

1.Essential:

Master's or Ph.D. in Life Sciences, Biotechnology, Pharmacy, or Clinical Research.

2+ years of experience in clinical research, clinical trial management, or pharmacovigilance.

Strong knowledge of ICH-GCP guidelines, regulatory frameworks, and clinical trial protocols.

Knowledge on CR related free tools/AI tools/softwares (RapidMiner; Knime, OpenFDA API, PubChem API, EMA/FDA Sandbox, Rasa etc.)

Prior teaching or corporate training experience in Clinical Research.

Excellent communication, presentation, and mentoring skills.

2.Desirable:

Industry experience in clinical trial management, CROs, or pharmaceutical R&D.

Knowledge on AI Tools used in CR protocol design (clinical research trials, data visualization, cleaning and preprocessing (eg: using Google Collab(Python Basics, Data Handling, etc,)).

Certification in Clinical Research (e.g., CCRP, ACRP, DIA).

Hands-on experience in clinical data management and regulatory submissions.

Why Work at Biotecnika

• Be a Leader in Clinical Research Training Shape the careers of future clinical research professionals.
• Work with Industry Experts Collaborate with professionals from CROs, pharma, and regulatory bodies.
• Career Growth & Learning Opportunities to expand into training, research, and industry collaborations.
• Innovative Learning Environment Access to cutting-edge tools, case studies, and real-world applications.
• Work-Life Balance 5-day workweek, competitive salary, and a dynamic work culture.