Maximum Allowed Duration: 3 Months
Expected Effort: 10-15 hours/week
A Clinical Research Associate (CRA) is a professional who monitors clinical trials and research studies.
A Clinical Research Associate (CRA) is a specialist who tracks clinical trials and research studies. CRAs may be hired either by the Pharmaceutical or Biotech Business, the Contract Research Organization (CRO), the Independent Consultant or may act as freelancers. CRAs follow FDA-approved methodology, track clinical trials and ensure that clinical trials comply with established guidelines, regulations and standard operating procedures (SOPs). The CRA is independent of the clinical investigator sites and must not have any conflict of interest that could possibly affect their ability to track clinical trials. CRAs play a key role in the production of all medicines and tools that make them available on the market.
Benefits of CRA Training & Certification:
Sponsors, CROs and other agencies involved in the implementation of clinical trials and other forms of medical research are increasingly looking for qualified individuals who have completed formal and approved training and certification in order to be able to rely on them to perform the tasks assigned to them. CRA output is crucial to the success of the project.
CRA Training & Certification:
The CRA Training & Certification Program, which leads to the award of the CRS Certified Clinical Research Associate, helps new or experienced CRAs demonstrate their professional competence through a validated training & certification process. It goes a long way to being a valuable addition to history, schooling, work experience and an adequate training in clinical research. CRA Certification also allows for personal satisfaction and enhanced appreciation of colleagues, managers and the industry as a whole.
.CRA Training & Certification Program Structure:
Upon registering for the CRA Training and Certification program, members are granted access to the CRS learning and certification platform. The online CRA Training & Qualification Program is a 40-hour standardized program that provides core clinical study learning. These are some of the important areas in which training is received after the qualification curriculum has been signed.
This study module, which consists of several lectures and presentations, introduces the participant to the pharmaceutical and clinical research industry.
It also allows for a thorough overview of the clinical research field and the development and developments that have led to the current clinical research environment. The Introductory Module also teaches individuals about clinical research stakeholders and the Principles of Good Clinical Practice (GCP). Technologies in the management of clinical trials are discussed in detail, and comprehensive knowledge of the major clinical research regulatory bodies that exist globally is also provided to individuals.
This program consists of multiple lectures and includes instruction on the pre-clinical development of drugs and biologics, different stages of clinical drug development, design of clinical trials and endpoints in clinical trials.
Ethics in Drug Development:
Each series, consisting of multiple lectures, discusses the concept of ethics in clinical research, the Informed Consent Process, Evidence and HIPAA, and also offers instruction at the International Conference on Harmonization (ICH).
Regulations in Clinical Research:
This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, and 814.
Roles & Responsibilities:
It is important to identify the roles of all stakeholders in the management of clinical trials so that standards that are realistic can be established. Each section provides a comprehensive overview of the roles of clinical practitioners, sponsors, suppliers and the Institutional Review Boards (IRB).
Essential records are documents which, individually and collectively, make it possible to assess the conduct of the trial and the quality of the data generated. These records provide proof of the investigator’s compliance, support and evaluation with the Good Clinical Practice guidelines and all relevant regulatory requirements.
One of the most important and frequent inspection findings during investigator site inspections is the inadequacy of reliable and accurate source reporting. This is also the most common pitfall found during sponsor audits. To order to ensure that the results of the study are focused on reliable and relevant data, the value of good documentation practice needs to be stressed for the investigator sites. This curriculum focuses on the core principles of good data practice, offers intensive training to key areas such as source documentation, main documents, IND & NDA Requirements and the Clinical Study Report (CSR).
Each section provides an overview of clinical procedures in the start-up phase of a clinical trial. A Study Start-Up Group, vendors and sites identified and activated, procedures established for data collection and reporting, and regulatory approvals obtained shall be established from the final procedure to the first patient visit. The program offers focused instruction in areas such as feasibility evaluation, site selection, pre-study visit, site initiation, recruitment and retention of participants, the TMF (Test Master File) and budgeting of clinical trials.
Study Monitoring & Close Out:
The monitor is responsible for “surveillance the conduct of a research project.” Research monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned research protocols. A major part of the reporting duties is to inform and assist sites in compliance with FDA and other local and international regulations and/or recommendations, while also helping them meet the requirements of specific research studies. Monitors act both as communication channels between sites and sponsors and as supervisors for individual research projects. This program offers extensive training in areas such as regular site monitoring, CRF analysis and source data verification, product transparency and compliance, site closure, writing accurate monitoring reports and follow-up visit letters, and record archiving and maintenance.
One of the CRA’s most important priorities is to ensure that clinical inspectors are fully aware of and comply with their responsibility for reporting adverse events. To do it, the CRA must often notify investigators of the criteria for adverse event reporting. As a result, the CRA must be aware of both the regulatory and sponsor-specific criteria for reporting significant and non-serious adverse events in clinical trials. It requires the proper use and completion of adverse event forms and criteria and conditions for reporting adverse events that may go further than the regulatory requirements. Each program offers instruction in the identification and monitoring of adverse and serious adverse events in clinical trials.
Role of Quality Assurance & Data Management:
Each program offers relevant training in quality assurance (QA) audits and testing, electronic data and signatures, information management and biostatistics..
MODE OF STUDY: E-LEARNING
All Program material will be provide once student is registered.
The curriculum for the Clinical Research Associate (CCRA) program is comprehensive, has been developed and validated by seasoned industry professionals and is fully supported by the clinical research industry. Not only is this curriculum ideal for new graduates, as well as for working professionals who either plan to grow further in their clinical research and/or pharmacovigilance careers, or who intend to move from another related field to clinical trials or pharmacovigilance.
You will be evaluated on a continuous basis by the faculty on the basis of the following conditions:
one is the completion of the online multi-choice question tests that accompany each lesson; and the other is the timely submission of tasks for each study module within the PHARMA RESEARCH e-Campus. The academic performance in the program will be measured on a scale of 4 GPA points.
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) would include either of the following:
– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
As a student, you can connect online with faculty and fellow students to network and discuss specific topics through your e-campus. The Faculty shall promptly respond to questions related to the research in the Online Campus Tutoring Center (OCTC).
Towards the end of the course, you will be provided with placement support if needed and career development support through the “Student achievement Group.” In addition, each participant enrolled in the CCRA Course is presented with a mentor who is an accomplished clinical research professional. The tutor can be contacted at any time via e-mail or phone.
Training & Certification Fee:
CCRA Fee: $600 USD
From 01 April 2018 CRS only issues soft copies of certificates. These are sent to the applicant’s email usually within 2 weeks of certification exam.
Maintenance of Certification:
Certifications should be renewed every two (2) years from the date of the initial certification. Maintaining certification requires completion of the Learning & Online Test. This can be accomplished by adding the accumulation of credits through Continuing Research Education (CRE) AND / OR the accumulation of credits through Continuing Professional Engagement (CPE).
CRA certification maintenance fee is USD 130/-every two years
At PHARMA RESEARCH, we seek to cultivate clinical research and pharmacovigilance practitioners who are trained with the most applicable and up-to-date knowledge and skills. This is achieved through the diversity of our innovative and unique online clinical research and pharmacovigilance training programs of high quality.