On-Site Training Program in Clinical Research

CLINICAL RESEARCH (CR) OVERVIEW

The worth of global clinical research market has reached to US$ 64 billion with more than 155000 trials till date, where India is expected to conduct 5% of clinical trial (currently 2600+ trials) due to Low cost, higher recruitment rate, sound infrastructure, large population size, qualified professionals.

The On-Site Clinical Research Training Program is a unique initiave where the trainees will be trained under industry experts at Multi Speciality Hospital, New Delhi, India. The timings of the program would be Monday to Friday (9:30 AM to 5:00 PM)

LEARNING OBJECTIVES

  • To impart clear and deep understanding on various essential elements of Clinical Research and ICH-GCP.
  • To provide on-site training and theoretical knowledge on various essential CR topics.
  • To train on Roles and Responsibilities of CR personnel along with its application required to execute at various levels in clinical trials.
  • Provide a unique opportunity for the trainees who make a significant impression during their training period - they will have their training converted into a full time job.
  • Provide a unique opportunity for the trainees to get train and career guidance from industry experts.

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Curriculum

Topics: On-Site Training

  • Case Studies and Training on: Protocol, Informed consent process, Screening procedures, Randomization process (IVRS/IWRS), Subject retention, Subject scheduled and unscheduled visit, Reporting of SAE/AE, EC Communication, Archival
  • GCP training: Online GCP training Certificate
  • Exploring Various Visits: Site Selection Visit, Investigator Meeting, Site Initiation Visit, Monitoring Visit, Audits, Interim, Close Out
  • CRF Overview: e CRF, RDC, Paper CRF
  • Handling IP Goods: Drug Receipt & Acknowledgement, Drug Dispensing, Drug Compliance, Drug Reconciliation, Drug Destruction
  • Handling Lab samples: Processing of Samples, Packaging (Ambient & Frozen), 
  • Source Documentation
  • IT Skill Development
  • Periodic communication and personality development sessions.

Topics: Theory

  • Introduction to Clinical Research and Pharmaceutical Medicine
  • Ethics in Clinical Research
  • Roles & Responsibilities of Clinical Research Personnel
  • Guidelines & Regulation Associated with Clinical Research
  • Essential Clinical Trial document
  • Importance of Informed Consent Documentation
  • Importance of Safety Reporting
  • Recent Trends in Clinical Research
  • Careers in Clinical research
  • Clinical Research Glossary & Common Abbreviation

Eligibility

  • Pharmacy Students (Pursuing or completed): B.Pharm, M.Pharm
  • Life-Sciences Students (Pursuing or completed): B.Sc, M.Sc
  • Medicine Students (Pursuing or completed): BDS, MDS, MBBS. M.D., M.S, MCh
  • Alternative Medicine (Pursuing or completed): Ayurveda, Unani, Yoga, Siddhi, Homeopathy, Traditional Medicine etc.
  • Nursing (Pursuing or completed): B.Sc., M.Sc.
  • Industry Personnel
  • Clinical Research Personnel: CRC, CRA, CTA, Clinical Trial Investigators
  • PhD

Online Enrollment Procedure

Step 1

Click button Enroll Online and then Click Checkout button

Step 2

Complete and submit the Registration Form, followed by Checkout button

Step 3

Choose convenient Mode of Payment and Make the Payment

Step 4

Get Instant Access* to Login Details along with Study Material & Assignment.

*Instant access is applicable only to participant who have selected online mode of learning. For offline (distance) mode of learning, the study material and assignment will be dispatched to their corresponding address on the last date of registration of that batch.



Offline Enrollment Procedure

Step 1

Download the Offline Enrollment Form present on respective pages of courses

Step 2

Send the completed enrollment form along with the fee (details mentioned on enrollment form) on our official address

Step 3

Dispatch of course material along with assignment on your corresponding address.

Course FAQs

What is Clinical Research?

“Clinical research is a branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use” or “We can say that clinical research is an important part of the drug/device discovery and development to ensure that the drug/device to be marketed is safe and effective on human usage”.

What is the career growth in Clinical Research industry after completing on-site Training?

The career growth in CR industry is as follows:

Physicians: Principal Investigator, Co-investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager and Clinical Research Physician etc. 

Others:Clinical Research Coordinator (CRC)/ Clinical Research Associate (CRA) >> Sr. CRA >> Project Manager >> Team Leader >> Operations Manager >> Director

Why should I pursue this course?

This hands on training program will offer you the following inherent advantages to excel your career growth by:

  • Providing an in-depth knowledge in clinical research and GCP (Good Clinical Practices)
  • Increasing the visibility of your CV among potential recruiters
  • Increase the acceptance in companies’ for jobs
  • An opportunity to explore career in clinical research domain as CRC/ CRA

Where I can apply after completing On-Site Training Program?

After successfully completing this training one can join industry as Clinical Trial Coordinator (CTA/ CRC) with Hospital Sites or as a Clinical Trial Associate (CTA/ CRA) with sponsor companies (Pharmaceuticals/ Biotech), Contract Research Organizations (CROs),Site management Organizations (SMOs), Research Institutions etc.

For more details on courses, fees, enrollment, Result, Assignments, Certificates, Placements visit our General FAQs section.

Course Code : SC-101-08
Level : Beginner/ Intermediate
Mode of Learning : Regular
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 49500
Current Batch : December
Duration : 2 Months

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