Clinical Research Associate

Structural Element

NSQF Alignment : LFS/Q03501,  Level 5 of Life Science Sector Skill Development Council

Structure : 

Semester I : 

Six months of Training - Theory and Practical (535 hours)

Students will have options to select electives in any 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 are eligible : 

• B. Sc. (Biology, Nursing, Medical Lab technician, Life Sciences , Biotechnology, Pharmaceutical Science)/ B. Pharma / B. Tech (Bio Technology)/ Micro Biology

• 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 details, documentation

Elective Integration: 

• Site Management

• Clinical Research Trial Management

• Data Management

Students can take all three together or any one more of the electives. But we have made A and B as compulsory

Apprenticeship/ Internship

• Apprenticeship will be with companies based on any elective you prefer

• Students completing Semester I will be provided Apprenticeship opportunity in various Healthcare Establishments/ Pharma Companies, CROs, under National Apprenticeship Program of GOI. or Internship at Healthcare Establishments or at CRO sites.

• Students will get stipend per month,depending upon whether it is through GOI under NAPS or through Healthcare Establishments/ CROs as internship.

• Stipendiary support to students, who will be engaged in industry as an apprentice, will be as per 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 environment 

• Field work, several assignments, live protocol design, opportunity to witness ethic 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, 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 wellbeing 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, managing the patient selected for 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 on a regular basis

• Perform 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 supervisor, colleagues and respond to audit queries during GMP/ regulatory audits. 

• Verify that data entered on to 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 and 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 final research report

Program Uniqueness

The course covers the entire lifecycle of Clinical trial 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 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 is built in the curriculum. Students earn in 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 trial 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 tremendous dearth of skilled resources.

Any organisation intending to get into Clinical Research will need skilled resources as Clinical Research associate so that they can confidently create clinical research sites in their organisation.

Going by increased health consciousness Pharma companies are coming 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 are manifold in increase in CR sites. But industry is not getting resources who can support in the entire value chain from pre-site works to site readiness, site management, regulatory works, data management  and reports