Who is a Clinical Research Associate?
A clinical research associate is a health care professional who performs many activities related to medical research, specifically clinical trials. A clinical research associate is employed by either a pharmaceutical company or a contract research organization which works on behalf of pharmaceutical companies. Since, clinical trials may be carried out at various phases, trials on patients with a disease and studies conducted after the launch of a new drug to monitor safety and side effects. A CRA will be involved in all stages of the clinical trial, including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
Roles and Responsibilities of a Clinical Research
A Clinical Research Associate has certain roles and responsibilities. Listed below are some common on-the job responsibilities of a CRA:
• Travel to and monitor clinical trial sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed
• Preparing site visit reports
• Ensure that only qualified individuals are working as site staff and that they are adequately trained
• Ensure data collected is accurate and verifiable
• Manage clinical trial site payments and handle any ongoing negotiations
• Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study
• Act as a mentor to site staff and provide continuous support and guidance
• Ensure appropriate filing of study documents and archival
Therefore, prepare one for the daily routine as a clinical research associate.
Skills Required as a Clinical Research Associate
Clinical Research associates require certain skills or competencies to carry out their daily tasks, roles and responsibilities. They are listed below:
Excellent oral and written communication skills and the ability to build effective relationships with trial center staff and colleagues
The capability to motivate others
An eye for detail
The ability to multi-task and think on one's feet
Good organizational, IT and administrative skills as the job involves lot of documentation and recording of information through computerized processes such as clinical trial management systems and electronic data capture.
Career Prospects /Career Path as a Clinical Research Associate
After completing their clinical research courses, clinical research professionals can gain experience in the clinical research industry. Once, they gain experience in the fields of health-care and clinical research, Clinical Research Associates can move on to the following job profiles:
Lead Clinical Research Associate
Clinical Research Head
Project Manager
Clinical Operations Director
Hence, the job profile of a Clinical Research Associate opens various doors to career opportunities in the pharmaceutical research and development sector for positions in pharmacovigilance, regulatory affairs and marketing.
To sum up, clinical research courses opens the door to various career opportunities as a clinical research associate. Once, a CRA has several growth potential once they gain experience. One just has to enroll in the best clinical research training institute in Pune.
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How to start careers as a Clinical Research associate
RandomA clinical research associate is a health care professional who performs many activities related to medical research, specifically clinical trials.