This is one of our trending certification courses on Clinical Research Associate (CRA), designed for college students and working professionals from the pharma, medicine & life sciences. The CRA course is being delivered jointly with the SHRM Skill & Innovation Foundation.
Why this course
Clinical Research is a Life Science domain that has grown significantly in the post-COVID environment, and there is a tremendous dearth of skilled resources.
Any organisation intending to get into Clinical Research will need skilled resources as a Clinical Research Associate, so that they can confidently create clinical research sites in their organisation.
Going by increased health consciousness, Pharma companies are coming up with newer drugs, enhancing efficacy, and new processes.
As a result, several healthcare establishments and CROs are getting into Clinical Research as a business opportunity. Consequently, there is a manifold increase in CR sites. Check out our other training areas in biosciences.
Structural Element
NSQF Alignment: LFS/Q03501, Level 5 of Life Science Sector Skill Development Council
Course Structure:
Semester I:
- Six months of Training – Theory and Practical (535 hours)
- Students will have options to select electives in any one or more of
- a) Site Management
- b) Clinical Research Study Monitoring
- c) Data Management
Semester II: Six months of Apprenticeship (1020 hours) on any elective
Certification by: Life Science Sector Skill Development Council, NSDC, Ministry of Skill Development and Entrepreneurship, Govt of India.
Who is eligible:
- B. Sc. (Biology, Nursing, Medical Lab technician, Life Sciences, Biotechnology, Pharmaceutical Science)/ B. Pharma / B. Tech (Bio Technology)/Microbiology
- M. Pharma / M. Sc / PhD in Pharmacology
- BDS/ BUMS/ BAMS/ BHMS. Medical Graduates will also qualify
Added prerequisites
Flair for research, process orientation, attention to detail, and documentation
Elective Integration:
- Site Management
- Clinical Research Trial Management
- Data Management
Students can take all three together or any one of the electives. But we have made A and B compulsory
Apprenticeship / Internship
- Apprenticeship will be with companies based on any elective you prefer
- Students completing Semester I will be provided an Apprenticeship opportunity in various Healthcare Establishments/ Pharma Companies, CROs, under the National Apprenticeship Program of GOI, or an Internship at Healthcare Establishments or at CRO sites.
- Students will get a stipend per month, depending on whether it is through GOI under NAPS or through Healthcare Establishments/ CROs as an internship.
- Stipendiary support to students who will be engaged in industry as an apprentice will be as per the prescribed stipend guidelines.
- Will be in any one of the Electives
Delivery
- This course will be exclusively offered by SHRM Bio-Tech Pvt Ltd with tripartite collaboration – SHRM Skill, Industry Collaborator, and LSSSDC
- Blended Mode of Delivery
- Practicals supported by Healthcare establishment / CRO, and also in demo and mock environments
- Field work, several assignments, live protocol design, and an opportunity to witness the ethics committee proceedings
- Opportunity to get engaged with CR trial sites during the course duration.
- Assessment will be done by LSSSDC both after Semester I and Semester II. For Semester II, the apprenticeship / Internship will be run jointly by the parties.
What You Learn & Coverage
- Will be involved in the entire value chain of clinical trial and research, right from regulatory approval, protocol, managing trial sites, trial monitoring, research reports, and approval support.
- Clinical trial site readiness, engagement during trials, impact of quality assurance, and audits in clinical research
- Will be able to monitor clinical trials for effectiveness, ethical practices, Safety, and participant’s during a clinical trial for safety and their rights
- Perform the required activities to effectively report and document the clinical trials monitoring process
- Develop and write trial protocols (outlining purpose and methodology)
- Present trial protocols to a steering committee
- Design data collection forms, known as case report forms (CRFs)
- Coordinate with the ethics committee, which safeguards the rights, safety, and well-being of all trial subjects
- Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- Identify & assess the suitability of facilities to use as the clinical trial site
- Identify/select an investigator who will be responsible for conducting the trial at the trial site
- Thorough understanding of the required elements of the informed consent, managing adverse impact, and managing the patient selected for the trial
- Liaise with doctors, consultants, or investigators on conducting the trial
- Set up the trial sites – ensuring each centre has the trial materials, including the trial drug, often known as the investigational medicinal product (IMP)
- Monitor the trial throughout its duration, which involves visiting the trial sites regularly
- Perform the role as Clinical Research Coordinator in compliance with Good Manufacturing Practices (GMP) and GCP(Good Clinical Practices) and other environmental regulatory guidelines.
- Demonstrate good documentation practice (GDP) and data integrity while reporting and documentation as per standard operating procedures (SOP), good laboratory practices (GLP), and Good Manufacturing Practices (GMP).
- Demonstrate how to coordinate with the supervisor, colleagues, and respond to audit queries during GMP/ regulatory audits.
- Verify that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
- Collect completed CRFs from hospitals and general practices
- Write visit reports, file, and collate trial documentation and reports
- Ensure all unused trial supplies are accounted for
- Close down trial sites on completion of the trial
- Assist in preparing the final research report
Program Uniqueness
The course covers the entire lifecycle of clinical trials and research that an associate has to perform. The person will be the key resource in the entire trial and research process
Curriculum designed in collaboration with industry and Life Science Sector Skill Development Council (LSSSDC) that covers the entire value chain from pre-site works to site readiness, site management, trial coordination, regulatory works, data management, and reports
Students get the opportunities to do field work at the actual sites even before the internship starts, thus providing live experiences. Industry tie-up with key users of the resources for training support and internship
Six months of paid internship/ apprenticeship are built into the curriculum. Students earn in the last 6 months
Several project assignments and interactive sessions, contents and Certification from LSSSDC, Govt of India.
Golden opportunity for bio science, pharma students, bio-technology, micro-biology, physiology/ pharmacology, BDS/ BHMS students to boost their career in their study domain in the emerging clinical trial landscape
Delivered by Doctors and Clinical Research experts engaged with clinical trials and research
Extensive soft skill classes and grooming
What Industry is looking for
Clinical Research is a Life Science domain that has grown significantly in recent times, and there is a tremendous dearth of skilled resources.
Any organisation intending to get into Clinical Research will need skilled resources as a Clinical Research associate, so that they can confidently create clinical research sites in their organisation.
Going by increased health consciousness, Pharma companies are coming up with newer drugs, enhancing efficacy and new processes
As a result, several healthcare establishments and CROs are getting into Clinical Research as a business opportunity. Consequently, there is a manifold increase in CR sites. But industry is not getting resources that can support the entire value chain from pre-site works to site readiness, site management, regulatory works, data management and reports.