Clinical study. Clinical trial. Clinical protocol. They all mean the same thing–a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.
Many new medicines and treatments are found to be helpful and safe in test tubes and in animals. They must also prove safe and effective in humans before doctors can prescribe them.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger-scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Clinical research is a rapidly growing field, offering numerous employment opportunities for qualified professionals. Graduates of AAPS Post-Graduate Diploma program can find employment in
Graduates of AAPS Post Graduate Diploma in Clinical Research can take on the following roles
A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP).
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations.
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
How to monitor a study in the field requires considerable thought. Almost all field monitoring requires regular visits to the site by the clinical research associate throughout the period of the study. On very rare occasions, an extremely simple, low-risk study might be monitored almost exclusively by telephone except for the startup and closeout visits.
A clinical research associate (CRA) must determine how to integrate telephone, email, fax, and regular mail communications into a monitoring strategy. This will differ among programs and sites depending on available technology, sponsor and site Standard Operating Procedures (SOPs) and personal preference. In monitoring, like any business, many problems can be traced back to a lack of communication, inappropriate communication and/or unclear communication. A good communication strategy should have a high priority in your monitoring plan.
Typically a starting salary for entry level/Junior clinical associate is around $45k plus benefits.
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