Roles and Responsibilities of  A Clinical Research Coordinator 

A clinical research coordinator (CRC) or the study coordinator is a specialized research person working under the direction of the Principal Investigator , who is responsible for conducting clinical trials at clinical trial sites according to the protocol, ICH-GCP and other regulatory requirements. where as the CRC works with the sponsor department, and institution to support and provide guidance on every related aspects of the study.

 Every clinical research project might have one or more study coordinators depending upon the work load at the trial site. Clinical trials at site level are classified into 3 stages. The three stages and the role of the coordinators at these stages are;

1) Before starting the clinical trial 

2) During the conduct of the clinical trial 

3) After finishing the clinical trial

Before starting the clinical trial;

 The coordinator collects

and completes the queries received from different clinical research organizations and sponsors. They need to collect the required information from the Principal Investigator and send to the particular people who contacted the site regarding the study.

 Participating in investigator meetings

 Preparation and submission of EC Dossier to EC of site for approval

 Analysis of cost and budget negotiation

 Contracting with pharmaceutical companies

During the conduct of the trial;

 Understanding of the study protocol and must know well about the inclusion and exclusion criteria

 Subject recruitment and retention related activities

 Participating with Principal Investigator and in the process of Informed consent form (ICF)

 Preparing and maintaining all the types of documents

 Storage and study drug accountability

 Maintaining IVRS( interactive voice responsive system) and IWRS( interactive web responsive system)

 Patient safety and care and appropriate visit conduct for the patient

 Checking all the central lab reports which are reviewed and signed by the Principal Investigator 

 Maintaining the records and report adverse event or the serious adverse events within timelines and their follow-ups 

 Filling up-to-date electronic case report forms

After finishing the clinical trials;

 Before a clinical research trial is closed at the site , study coordinator must validate all the documents and all the documents what to be updated

 On the final day CRC will verify all the documents ,once after verification CRC will assist in archiving the documents at site 

 The site has to maintain all study related records for 15-20 years

Responsibility of clinical research coordinator;

The CRC’s main responsibility with all clinical research staff is to ensure the protection and well-being of the patients participating in the study , which includes

 Take part in preparation and control of research budgets and financial payments

 Notify subjects regarding all study aspects related 

 Entering the study data into applicable database

 keeping the study activities to make sure compliance with protocol and all related local, regulatory and institutional policies

 managing necessary records of study related activity which includes case report forms, drug dispensation and records etc

 communicating with the laboratories or researchers about laboratory findings

 collection, labeling, storage, or shipment of samples

 enroll subjects in the study as per the study protocol

 prepare advertising and other educational materials and conduct campaign for clinical trials

 arrange space for study equipment and other trial related material

 monitor enrolment status of participants and record dropout causes and subject contact efforts

 overview proposed study protocols to assess factors such as sample collection procedures, data management issues, and possible subject threats

 record adverse event and side effect information and consult with investigators concerning the reporting of events to regulatory agencies

 prepare trial-related paper work such as protocol worksheets, procedural manuals and progress reports

 maintain subject registration to make sure that information consent is effectively obtained and recorded

 keep in touch with the sponsors to schedule and coordinate site visits or to answer queries

 Dispensing the study medical devices or drugs to subjects, determine dosages and deliver instructions as necessary

Conclusion;

To sum up, the workload of CRCs can greatly vary from site to site which depends on many factors such as the nature of the study, the number of enrolled patients , the number of active studies,. The longevity  of patient visits, etc. In any case, there can be periods of time when the CRC is overworked, but there will also a period when they are underworked. A coordinator who’s constantly overworked wont be able to perform well.

References;

1. The European agency for the evaluation of medicinal products, ICH Topic E6. Guideline for good clinical practice. Note for guidance on good clinical practice.

2. Stephens L, Papke L. Certified clinical research coordinators. Appl Clin Trials. 1995;4:58-63.

                         I pay my sincere thanks to the mentor and our core trainer, Mujeebuddin sir, Founder and CEO of Clinosol Research Pvt.Ltd., for driving me throughout the entirely of this log and the management of clinosol for supporting me to post this free and for helping me spread knowledge I have gained to all my friends and to the society.

                                     By D. YAMINI SAI NIKITHA

                                                   B. PHARMACY

              SRINIVASRAO COLLEGE OF PHARMACY

                                                   VISAKHAPATNAM

                                     INTERN AT CLINOSOL RESEARCH PVT.LTD

                                                    STUDENT I.D- CSRPL_INT_ONL__WKD_0075/