Certified Clinical Research Coordinator
The Clinical Research Coordinator (CRC) is a research professional who specializes in working with and under the direction of the Clinical Investigator. While the Clinical Investigator is primarily responsible for the overall conduct, and management of the clinical trial at the investigator site, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By assuming these responsibilities, the CRC works with the clinical investigator, research department, sponsor, CRO, the and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study. The CRC may be in direct control of recruitment and retention of research subjects for the research study. A few standard tasks performed by a CRC include patient registration/randomization, recruitment follow-up, CRF completion, collaboration with the CRAs, Serious Adverse Events (SAE) reporting, investigator file handling, and preparing the site for and/or attending audits. In addition, it is not uncommon for the CRC to liaise with the pharmacy. CRCs are also involved in administrative activities (such as IRB submission and scheduling patients’ appointments), and various clinical activities (inclusion/exclusion criteria assessment and completion of scales/questionnaires) if qualified and designated by the Clinical Investigator to do so.
Benefits of CRC Training & Certification:
Sponsors, Contract Research Organisations, Site Management Organisations, leading hospitals and other agencies involved in the conduct of clinical trials 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 CRC is critical to the success of a clinical research 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 this data is collected and handled, and the protection of research subjects, to name a few. The CRC Training & Certification Program which leads to the award of CRS Certified Clinical Research Coordinator helps new or seasoned CRCs to demonstrate their professional excellence through a validated 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. CRC Certification also provides for personal satisfaction and increased recognition by peers, supervisors and the industry at large.
Eligibility:
To be eligible for this certification program, applicants have to demonstrate a combination of educational background and evidence of work experience in clinical research. The applicants have to suffice the eligibility requirements as per one of the categories listed in the table below:
View the Eligibility Table
CATEGORY EDUCATION WORK EXPERIENCE IN PERFORMING CORE CRC 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.
CRC Training & Certification Program Structure:
After registering for the CRC Training and Certification program, members are provided access to the CRS learning and certification portal. The CRC Training & Certification program is a 40 hour structured program that delivers core trainings in the area of clinical study conduct at the investigator site. Care has been taken to impart trainings from a clinical investigator site perspective. 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 Site Management & Close out:
CRCs play a key role in the implementation of clinical trials at the clinical investigator site, which goes far beyond mere data collection and/or administrative support, and directly contribute to the gathering of good quality data. This module trains the CRC on critical aspects of study management at the site. Some of the important areas discussed are patient counseling, recruitment and follow-up of subjects, protocol compliance, minimizing and addressing protocol deviations, communicating with IRB, completing CRFs, drug accountability and compliance, facing routine monitoring visits and audits, site close out, handling of blood samples, dry ice and other hazardous material, and document archival and maintenance.
Safety Reporting:
One of the important responsibilities of the CRC is to ensure that clinical investigator site is in compliance with its responsibilities for adverse event reporting. To achieve this, the CRC must be knowledgeable about the adverse event reporting requirements. Consequently, the CRC 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.
Training & Certification Fee:
Fee applicable for CRC Training & Certification is as follows:
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.
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 is of 2 hours 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 CRC 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.
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 CRC 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.
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