Certified Clinical Research Associate
A Clinical Research Associate (CRA) is a professional who monitors clinical trials and research studies. CRAs can be either employed by a Pharmaceutical or Biotech Company, Contract Research Organization (CRO), Independent Consultant or may act as freelancers. CRAs practice FDA-approved methodology, monitor clinical trials and ensure that clinical trials adhere to established guidelines, regulations and Standard Operating Procedures (SOP’s). The CRA is independent of the clinical investigator sites and must not have any conflict of interest that may potentially influence their ability to monitor clinical trials. CRAs play a key role in the development of all drugs and devices that make it to the market.
Benefits of CRA Training & Certification:
Sponsors, CROs and other agencies involved in the conduct of clinical trials and other types of medical research are increasingly looking for certified individuals who have undergone standardized and validated training and certification so that they can be relied upon to manage the tasks given to them. The performance of a CRA is critical to the success of a project. Companies or organizations that are involved in the conduct of clinical trials must follow regulations and guidelines that define the quality of data generated by clinical research sites, the manner in which data is collected and handled, and the protection of research subjects, to name a few. The CRA Training & Certification Program which leads to the award of CRS Certified Clinical Research Associate helps new or seasoned CRAs to demonstrate their professional excellence through a validated training & certification process. This goes a long way to be a great value addition to their background, education, work experience and demonstrates adequate training in clinical research. CRA Certification also provides for personal satisfaction and increased recognition by peers, supervisors and the industry at large.
Eligibility:
In order to be eligible for this certification program, applicants have to have a combination of
educational background that they either obtained online or at a college campus and a substantial amount of work experience. If you do not hold a basic science background but have obtained a related qualification such as a Master of Health Care Administration or any other health care related degree and worked in a completely different setting, you are still eligible for this certification program and for employment in future. Usually the applicants must suffice the eligibility requirements as per one of the categories listed in the table below.
CATEGORY EDUCATION WORK EXPERIENCE IN PERFORMING CORE CRA TASKS * (IN HOURS) DOCUMENTS REQUIRED ( ALONG WITH APPLICATION OR WITHIN 7 DAYS OF APPLICATION)
Bachelor's Degree OR
Master's Degree OR
Registered Nurse (RN)Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
Bachelor's Degree OR
Master's Degree OR
Registered Nurse (RN) AND
Completion of an education program of more than 150 hours in clinical research Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program submitted along with online application or within 7 days of application through email.
Associates Degree Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
Associates Degree AND
Completion of an education program of more than 150 hours in clinical research
Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program submitted along with online application or within 7 days of application through email.
High School Diploma OR
LPN/LVN/Medical Assistant/ Research AssistantDetailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
High School Diploma OR
LPN/LVN/Medical Assistant/ Research Assistant AND
Completion of an education program of more than 150 hours in clinical research Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
CRA Training & Certification Program Structure:
After registering for the CRA Training and Certification program, members are provided access to the CRS learning and certification portal. The online CRA Training & Certification program is a 40 hour structured program that delivers core trainings in the area of clinical study conduct. Following are some of the important areas in which training is provided after signing up for the certification program.
Introduction:
This study module that comprises of multiple lectures and presentations introduces the individual to the pharmaceutical and clinical research industry.
It also provides for a comprehensive assessment of the clinical research industry and the history and milestones that have led to the present clinical research landscape. The introductory module also educates the individual on the stakeholders in clinical research and the Principles of Good Clinical Practice (GCP). Technologies in clinical trial management are discussed in detail, and the individual also is provided comprehensive knowledge on the major clinical research regulatory bodies that exist globally.
Drug Development:
This module comprises of multiple lectures and provides training on Pre-clinical development of drugs and biologics, various phases of clinical drug development, clinical trial designs and endpoints in clinical trials. Various clinical trial registries in use today will also be reviewed in detail in this module.
Ethics in Drug Development:
This module that comprises of multiple lectures explains the concept of ethics in clinical research, Informed Consent Process, Documentation and HIPAA and also provides training in 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 critical that responsibilities be defined for all stakeholders in the management of clinical trials, so that expectations that are reasonable can be defined. This module provides comprehensive understanding of the responsibilities of the clinical investigator, sponsors, vendors and Institutional Review Boards (IRB).
Essential Documents:
Essential Documents are documents, which individually and collectively permit evaluation of the conduct of a trial and the quality of the data generated. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
One of the most critical and common inspection finding during investigator site inspections is the inadequacy of reliable and accurate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be stressed to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This module focuses on the key principles of good documentation practice, provides intensive training on important areas such as source documentation, essential documents, IND & NDA Applications, and the clinical study report (CSR).
Study Start-Up:
This module provides an overview of clinical operations in the study start-up phase of a clinical trial. From final protocol to first patient visit, a Study Start-Up Team must be formed, vendors and sites selected and activated, processes established for data collection and reporting, and regulatory approvals obtained. This module provides focused training on areas such as feasibility assessment, site selection, pre-study visit, site initiation, subject recruitment and retention, trial master file (TMF) and clinical trials budgeting.
Study Monitoring & Close Out:
The monitor’s responsibility is to “monitor the conduct of a research trial”.
Study monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned study protocols. A major part of the monitor’s responsibilities is to advise and assist sites in adhering to FDA and other local and international regulations and/or guidelines while also helping them meet the requirements of particular research studies. Monitors serve both as communication conduits between sites and sponsors, and as managers for individual research projects. This module provides comprehensive training in areas such as routine site monitoring, CRF review and source data verification, drug accountability and compliance, site close out, writing effective monitoring reports and follow-up visit letters, and document archival and maintenance.
Safety Reporting:
One of the most important responsibilities of the CRA is to ensure that clinical investigators are fully aware of, and are in compliance with their responsibilities for adverse event reporting. To achieve this, the CRA must often teach the adverse event reporting requirements to investigators. As a result, the CRA must be knowledgeable about both the regulatory and sponsor-specific requirements for reporting serious and non- serious adverse events in clinical trials. This includes the correct use and completion of the adverse event forms, and definitions and terms of reporting adverse events that may extend beyond the regulatory requirements. This module provides training on documenting and reporting adverse and serious adverse events in clinical trials.
Role of Quality Assurance & Data Management:
This module provides relevant training in Quality Assurance (QA) Audits and Inspections, Electronic Records and Signatures, Data Management and Biostatistics.
Certification Examination:
CRS has partnered with ProctorU to offer proctored exams for all Certification Programs. To ensure integrity, security & consistency of the examination process, real people oversee proctored exams. Proctored exams are a required component of the certification programs at CRS. You can schedule an examination at your convenience after registering for the exam and paying the examination fee of USD 27/- on the CRS website. Scheduling of examinations with proctorU will not incur any additional cost unless the exam is scheduled within 3 days of the date of scheduling. The certification examination will be of 2 hour duration.
ProctorU allows individuals all over the world to take their exams online while ensuring academic integrity for the institution. ProctorU uses a three-step process to replicate the face-to-face proctoring experience over the Internet. Through this process, proctors can see the student, observe their computers, and know whom they are monitoring. ProctorU does this while adhering to the highest accreditation standards in the industry. ProctorU is a pioneer in the industry and serves close to 100 partnership institutions including Northwestern University, the University of Florida and the University of Illinois. You can find more information on ProctorU here.
While the training provided though our CRA training program is extensive and broad in scope, members are nevertheless tested on their understanding of GCP and site monitoring based upon other resources that he/she may have been directed to during their training. These resources may include the FDA website, international and/or local policies, regulations, and guidelines, best practices, etc. We provide an exhaustive list of such resources through our Learning & Certification Portal.
The certification exam must be taken within 3 months of registration.
Training & Certification Fee:
For CRS Professional Members: USD 130/-
For CRS Non-Members: Fee varies between USD 175/- and USD 235/- based upon the nationality of the Non-Member.
Certificate:
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 must be maintained every two (2) years from the time of original certification. Maintenance of certification requires the completion of 24 documented hours of activity. This can be achieved through the combination of accumulating credits through Continuing Research Education (CRE) AND/OR accumulating credits through Continuing Professional Engagement (CPE). More information about maintenance of certification is available here.
The fee for maintenance of CRA certification is USD 130/- every two years for CRS Professional Members (provided the membership is active) and varies between USD 175/- and USD 235/- every two years for Non members, based upon the nationality of the Non Member.
How to Apply?
Applications currently closed.
DEMO
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