Clinical Research Associate

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A clinical research associate is a person who would monitor the clinical trials and other clinical research studies. Clinical research associates are the people who would ensure that the clinical trials are going the way they should. A clinical research associate can also be called as 'clinical monitor' or 'trial monitor'. Being a clinical research associate, you will have the opportunity to work in various settings like:

- Pharmaceutical companies

- Medical research institutes

- Government agencies

- Clinical research organizations

- Contract research organizations

- Biotech companies

- Self-employment (1), (2), (3)

Job Description:

Clinical research associates are the professionals who are responsible for setting up, monitoring as well as the completion of clinical trials that are associated with the following of new and existing drugs:

- Effects

- Risks

- Efficacy

- Benefits

In any clinical research, the clinical research associate would have the key responsibility to check whether the safety and rights of human participants are preserved. In addition, he/she would verify that the reported data are accurate and verifiable. In addition to all these, being a clinical research associate, you will have to ensure that the clinical trials are conducted in compliance with the following:

- Approved protocol as well as amendment(s)

- Good clinical practice

- Regulatory authority requirement (3), (4)

Understanding the Duties of a Clinical Research Associate:

As a clinical research associate, you would require performing the following tasks:

- Designing the case record forms

- Locating the ideal facilities for the clinical study

- Liaising with doctors and some other professionals all through the study

- Coordinating with the ethics committee

- Making sure that the clinical trial supplies are accounted for

- Discussing the results of the tests with medical statisticians

- Performing data as well as document verification by making sure that the data entered into case record forms is in accordance with the patient clinical notes

- Taking detailed notes during clinical trials

- Preparing progress reports during all parts of the study

- Preparing ethics committee document for submission along with any other tools, templates or documents prior to clinical site initiation

- Attending and assisting with investigator meeting in:

o Presentations

o Training materials

o Logistic preparation

o Coordination

- Conducting clinical site feasibility and helping clinical trial managers in study feasibility

- Preparing and maintaining clinical study files which include:

o Trial master files

o Investigator site files

o Investigator files

o Study essential documents

o Regulatory documents

- Planning and performing site initiation visit, site monitoring visits and close out visits

- Reporting and following up of adverse events and/or serious adverse events with the concerned departments

- Preparing the site visit reports as well as the follow up letters

- Ensuring that the investigational products are returned back to the sponsor upon study completion (3), (4)

How to Become a Clinical Research Associate?

Educational Prerequisites:

In order to earn an entry-level job in clinical research arena, you need to have a bachelor's degree in any of the fields plus a certification or diploma in clinical research from any of the reputed institutions:

- Life sciences

- Nursing

- Biotech

- Medical sciences

You are suggested to earn a graduate degree since it would enable you to become eligible for senior level positions with higher pay scales.

Program Coursework:

Coursework includes the following:

- Clinical trial ethical issues

- Process of discovery and approval of drugs

- Medical terminology

- Biostatistics

- Clinical trials data management

- Monitoring plan

In addition, every clinical research associate must possesses good writing as well as speaking skills for the purpose of communicating with physicians, participants and with other researchers. Furthermore, the candidates must require computer skills and expertise in spreadsheet application. (1), (3)

Professional Certification and Practice:

In the United States:

In the United States, Association of Clinical Research Professionals is providing a certification for clinical research associates. The designation offered would be 'Certified Clinical Research Associate'. For becoming accredited, the clinical research associate must pass an exam.

Prior taking this examination, the particular candidate must show that he/she has worked for required hours consistent with the study protocols. This certification program is being accredited by 'National Commission for Certifying Agencies'.

There is another organization called 'Society of Clinical Research Associates' which is a non-profit organization involved in training and continuing education for clinical research professionals. This is also providing a certification program with the designation of 'Certified Clinical Research Professional'.

In India:

In India, the clinical research associate would require the knowledge on 'schedule Y amendments' in drug and cosmetic act (1945).

There are several famous institutes in India imparting education in clinical research. Among them, 'Academy for Clinical Excellence' and 'Institute of Clinical Research' is solely concentrating on this field. Academy for Clinical Excellence is a joint venture of:

- Pfizer India

- Bombay College of Pharmacy

- Suven Life Sciences

There are more than 33 programs which include the certification courses like:

- Foundations of Clinical Research and GCP

- Advance Protocol Design

- GCP for Investigators

- Clinical Research theory to practice

- IEC-Composition and Function

Institute of Clinical Research teaches full-time and part-time programs like:

- Masters in Clinical research + MBA

- MSC in Clinical Research

- PhD in Clinical Research

- Post-graduate diploma in Clinical Research

'Bombay College of Pharmacy and Cliniminds' is also offering courses in clinical research.

Certification in Clinical Trials Management:

This particular program would introduce to the implementation and management of clinical trials. The coursework includes:

- Clinical practices

- Drug development process

- Fundamentals of clinical monitoring

- Clinical research statistics

- Reporting adverse events

- Design of clinical trials

- Development and design of medical devices (2), (5)

Pay:

U.S. Bureau of Labor Statistics does not have any separate data for clinical research associate position. Hence, the average pay for this job position has been taken from PayScale.com. As per PayScale.com, the average pay for clinical research associate in the United States was $59,045 (as of October 2013). And, In India, a clinical research associate is earning an average pay of 266,109 INR per year (as of December 2014). (2), (6)

References:

(1) http://education-portal.com/clinical_research_associate_certification.html

(2) http://en.wikipedia.org/wiki/Clinical_research_associate

(3) http://jli.sg/blog/a-career-path-guideline-how-to-turn-out-to-be-a-clinical-research-associate-cra/

(4) http://www.academicinvest.com/science-careers/biochemistry-careers/how-to-become-a-clinical-research-associate

(5) http://studentcaring.com/scope-clinical-research-india/

http://www.payscale.com/research/IN/Job=Clinical_Research_Associate_(CRA)/Salary

About the Author

Tharani Rajamanickam's picture

I am Tharani. I have Bachelors degree in Biotechnology. I am passionate about the healthcare and medical industry and continue to explore, learn and share and I bring in a wealth of knowledge and expertise to help you keep updated with current trends and developments. I have gained a lot of experience in clinical field by working in clinical trials arena. Stay tuned..

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