Learn real site-based clinical research at an active SMO and graduate job-ready with a paid six-month internship across hospital, SMO and sponsor settings.

one-time · lifetime
This is our flagship onsite professional program, delivered from a live Site Management Organization where clinical trials are actively coordinated every day. Unlike classroom-only courses, you will train alongside working Clinical Research Coordinators, sit inside real site operations and handle the documents, systems and workflows that ICH-GCP and Indian regulations demand. The online theory you study here is the companion to daily hands-on practice at the site.
The included six-month internship is the core of the program. You will rotate through hospital-based investigator sites, the SMO coordination office and sponsor and CRO touchpoints, so you understand how a protocol moves from an Ethics Committee submission all the way to database lock. You will practice source documentation, informed consent support, Investigator Site File maintenance, safety reporting, electronic data capture and monitoring-visit preparation on genuine study workflows under supervision.
Graduates leave with an industry-recognized certificate, a separate internship certificate and, importantly, placement assistance built on the reputation and network of a functioning SMO. Because you will have performed the actual tasks that employers hire for, you interview as a candidate with real site experience rather than only theoretical knowledge. This is why the program is priced as a premium, career-defining investment.
Program Orientation and Clinical Research Overview, How the onsite program and internship work, what an SMO does, the end-to-end clinical trial lifecycle and the site roles you will perform.
The CRC Role and Site Operations, Day-to-day responsibilities of a Clinical Research Coordinator, the site workflow, the delegation log and structured communication with the PI, sponsor and monitor.
Source Documents and Informed Consent, Source documents and source data, ALCOA+ principles in practice, and the informed consent process at the site including re-consent and documentation.
Protocol, Investigator Site File and Essential Documents, Reading and following a clinical trial protocol, building and maintaining the Investigator Site File, essential documents and version control.
Ethics Committee Submissions, Preparing initial submissions, amendments, continuing review and SAE reporting to the Ethics Committee, aligned with India's New Drugs and Clinical Trials Rules.
Safety Reporting and Pharmacovigilance, Distinguishing AE, ADR, SAE and SUSAR, site reporting timelines and workflow, and investigational product accountability and storage.
What a Site Management Organization Does
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The Clinical Trial Lifecycle and Your Roles
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Daily Responsibilities of a Clinical Research Coordinator
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Site Workflow and the Delegation Log
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Communicating with the PI, Sponsor and Monitor
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Source Documents and Source Data
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ALCOA+ in Everyday Documentation
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The Informed Consent Process at the Site
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Reading and Following the Protocol
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Building and Maintaining the Investigator Site File
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Essential Documents and Version Control
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Preparing the Initial Ethics Committee Submission
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Amendments and Continuing Review
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SAE Reporting to the Ethics Committee under Indian Rules
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Understanding AE, ADR, SAE and SUSAR
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Site Safety Reporting Workflow and Timelines
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Investigational Product Accountability and Storage
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Electronic Data Capture and eCRF Entry
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Query Resolution and Data Cleaning
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Monitoring Visits, Audits and Inspection Readiness
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7 modules · 21 lessons · Preview lessons are free to read; enroll to unlock the full course.
Clins Research Academy
Clins Research Pvt Ltd is a Clinical Research Site Management Organization (SMO) based in Gurugram. Our courses are designed and delivered by practitioners with hands-on experience across the clinical trial lifecycle.