ISCRI professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, Quality Assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.
ISCRI conducts various programs for Clinical Research Professionals in order to create an internationally accepted level of knowledge, education and experience by which clinical research professionals will be recognized by the medical research community.
ISCRI offers the following courses for clinical research professionals:
Minimum eligibility for application to the ISCRI courses would be either of the following:
- MBBS graduate or BDS graduate.
- A graduate or post graduate in Bioscience/Life Sciences (with any of the following subjects:
Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology), a graduate or post
graduate in Chemistry with at least 50% marks in aggregate.
- A graduate or equivalent Degree/ Diploma in Nursing or Pharmacy.
- A graduate or post graduate in Pharmacy or Pharmaceutical Sciences.
- Note: All final year students are eligible.
- Class room training.
- Presentation by lecturers.
- Exercises for subjects in Preparation of site files, IMP management, Safety reporting, CRF & eCRF completion guidelines, IC (Informed Consent Forms), PIS (Patient Information Sheets), Essential documents preparation, EC submission / approval & notifications, Site management plan, recruitment management, Tracking systems & onsite practical training.
- Workshops are conducted by eminent professionals from the Clinical Research and pharmaceutical
industry, on case studies of real-life clinical research situations and role plays on various
responsibilities to develop problem solving skills in students.
- Case Studies of real-life Clinical Research situations and are asked to draw inferences and make suggestions.
Student will be certified upon completion of course along with internship. Students have to pass the written exams by scoring >60%, to qualify for internship & have to do project & presentation of a particular topic after internship to get certification.
Computers with internet connection in computer lab, Study materials, CDs, Note pads & Practical training at hospitals.
Note: Hostel facilities available for the students from far places.
Selection procedure:
The selection of individual students will be on the following procedure:
- Screening and selection of students based on merit.
- Written test.
- Personal Interview.
Awards & Recognisation
- ISCRI will nominate the Best student award & will be given preference for placement assistance.
- Placement assistance will be based on attendance > 80% and scores in the exams must be > 70%.
- Best Students with good interpersonal skills, communication skills & knowledge will be recognized in placements.
| Module |
Topic |
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|
| Module -I |
Introduction to clinical research & various guidelines |
| Module II |
Body systems, Medical Terminology & lab tests |
| Module III |
Site selection, site initiation, site monitoring , site close out |
| Module V |
Essential Documents & safety Reporting, ICF Process & Various system(IVRS, Central Lab, eCRF) |
| Module IV |
Recruitment, patient & IMP management |
| Module VI |
Investigators site management & quality management, Audit preparation |
Other services offered
- Business communication course.
- Presentation and public speaking classes.
- Resume writings & Facing Interviews.
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