Professional Certification in Clinical Research Associate (CRA)

The Certificate in Clinical Research Associate (CRA) is a program designed to provide practical knowledge of clinical trial monitoring, ICH-GCP, regulatory requirements, and CRA responsibilities. The program focuses on participant safety, protocol compliance, data quality, site oversight, and effective monitoring practices.

Participants will learn on-site and remote monitoring, RBM/RBQM, protocol and source document review, SDV/SDR, protocol deviations, AE/SAE assessment, investigator oversight, monitoring documentation, findings and escalation, and inspection readiness.

The program also includes industry-based case studies, virtual monitoring simulations, and practical exercises to develop job-relevant CRA skills.

Target Audience: CRAs and aspiring CRAs, CRCs, clinical research professionals, QA/RA professionals, pharmacists, life-science graduates, and professionals seeking careers in clinical operations and clinical monitoring.

Certified Study Resources

International Affiliation with

Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials

1. CRA Roles and Responsibilities in Clinical Trial Monitoring
2. Participant Safety, Data Reliability and Protocol Compliance
3. On-site, Off-site and Remote Monitoring
4. Critical Thinking and Professional Judgment in Clinical Monitoring

Module 2: Pharmacology – Concepts and Application in Clinical Trials

1. Application of Pharmacology Knowledge in CRA Monitoring
2. Adverse Events (AE) and Serious Adverse Events (SAE) Assessment
3. Concomitant Medication Review and Drug Accountability
4. Identification of Drug-Related Safety Concerns

Module 3: Drug Development Process and Clinical Trials – Phases and Trial Designs

1. Protocol Review from a CRA Perspective
2. Eligibility Criteria and Protocol Compliance
3. Identification and Assessment of Protocol Deviations
4. Critical Data and Critical Processes in Clinical Trials

Module 4: Ethics and Ethical Guidelines for Clinical Trials

1. Practical Application of ICH-GCP in Clinical Monitoring
2. Informed Consent and Participant Rights
3. Participant Safety and Ethical Compliance
4. Identification and Reporting of Ethical/GCP Concerns

Module 5: Regulations Guiding the Clinical Research Industry

1. Practical Application of Indian and International Regulations
2. Regulatory Requirements for Clinical Trial Monitoring
3. Regulatory Compliance and Inspection Readiness
4. Regulatory Findings and Their Impact on Site Quality

Module 6: Clinical Trial Monitoring – On-site, Off-site, Remote and Risk-Based Monitoring

1. Monitoring Visit Preparation and CRA Responsibilities
2. On-site, Off-site and Remote Monitoring
3. Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM)
4. Study Site Monitoring Plan and Monitoring Strategy

Module 7: Documentation and Data Management in Clinical Trials

1. Source Documentation and Source Data Review/Verification (SDR/SDV)
2. CRF/eCRF Review and Data Discrepancy Management
3. ISF/TMF Documentation and Essential Trial Records
4. Data Quality, Data Integrity and Documentation of Findings

Module 8: Quality Control and Clinical Trial Management

1. Investigator Oversight and Site Quality Assessment
2. Protocol Compliance and Quality Management
3. CAPA, Monitoring Findings and Escalation
4. Monitoring Reports and Inspection Readiness

Module 9: Clinical Trials – Medical Devices

1. CRA Responsibilities in Medical Device Clinical Trials
2. Device Accountability and Safety Monitoring
3. Protocol Compliance and Essential Document Review
4. Site Quality and Risk Assessment in Medical Device Trials

Module 10: Protocol Writing and Designing

1. Protocol Review from a CRA Perspective
2. Identification of Critical Data and Critical Processes
3. Study Site Monitoring Plan Development
4. Monitoring Strategy and Visit Preparation

Module 11: Clinical Trials – Latest Updates

1. Recent Regulatory and ICH-GCP Developments
2. New Drugs and Clinical Trials Rules, 2019 – Practical Application
3. Impact of Regulatory Updates on CRA Monitoring Activities
4. Emerging Trends in Clinical Trial Monitoring

Module 12: Industry-Based Case Studies

1. Mock Monitoring Package and Source Document Review
2. Identification and Evidence-Based Assessment of Monitoring Findings
3. Monitoring Documentation, Reporting and Escalation Decisions
4. Virtual CRA Monitoring Exercise and Practical Assessment

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certifications Programmes. 10+2 pass-outs are eligible for our Under Graduate Diploma and Diploma holders of two to three years course duration are also eligible for the PG Diploma.

Programme Duration

The minimum duration to complete the Professional Certification programme is 6 months and maximum is 12 months. Alternatively, this programme may also be completed in a short-term duration of 5 days.

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

Programme Deliverables

A comprehensive study material (for 6 months Professional Certification) for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online Live Classes/Part-time for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Assessment & Certification

All the participants are expected to appear for online assessment. After successful completion the participants will be awarded Professional Certification in Clinical Research Associate (CRA) by Faculty of Clinical Research and Drug Safety, IGMPI. For all the above mentioned elaborate study resources, assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Discipline in Classes and Examination

Every student is required to observe a disciplined behaviour during her/his classes, assessments & examinations and to follow instructions from the Professors. Any act of indiscipline may result into discredit & it will be mentioned in her/his academic report.

Placement Assistance & Corporate Relations

For the Post Graduate Diploma, Undergraduate Diploma, Executive Diploma and Professional Certification Programmes, we will provide placement assistance after the completion of the programme. The Institute has partnered with many organizations for providing placement assistance to its students. The robust placement cell comprises senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like , Jhpiego, SELCO Foundation, TATA Foundation, Samarthan NGO, PSI, UNICEF, WHO, HCL Foundation, IPE Global, Optum, PATH, AIIMS, Action against Hunger, Ekta Shakti Foundation, Seva Foundation, India HIV-AIDS Alliance, HLFPPT, Deepak Foundation, Novartis, LalPath Labs Ltd., Fortis Healthcare Ltd., HealthCare Global Enterprises Ltd., Indraprastha Medical Corporation Ltd., Narayana Hrudayalaya Ltd., Piramal Enterprises Ltd., Wockhardt Ltd., Cactus Communications, Public Health Foundations of India, Cytel, Religare Health Insurance Company Ltd., Deloitte, DuPont Sustainable Solutions, Bain & Company, Alvarez & Marsal, McKinsey & Company, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

IGMPI offers professional and industry oriented Certified programme in Clinical Research Associate thus opening doors for entry into the industries. Clinical research associates lend a hand in bringing new drugs in the market. CRAs can work in a pharmaceutical company or contract research organizations (CRO). It is important to understand that CRA involves around 50-60% of travelling. It all depends on the company that you are working for.

After completion of this course, professionals can work as an entry-level clinical research associate (CRA), this is the most commonly available position in the clinical research field. From there, you can progress to higher-level jobs such as a CRA team lead, CRA manager, or clinical project manager (CPM). There are different levels that you can work towards, each with its own set of responsibilities.

A CRA position is not just organizing trials. There is also science and public relations involved. The opportunities in this career path are nearly limitless.

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Apply Online

Last date for submitting completed Application Form: 15^th Oct 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in