Author: Dr Sumit Shrivastav, CRAA
Pharmacists are professionals who best understand the nature of a drug inside human body. Typically, pharmacists routinely review medication orders, prescriptions, and medication profiles to ensure appropriate drug selection, doses, and dosing schedule. They look for drug-food interactions that may be harmful. If they identify a drug related problem or detect a potentially dangerous situation, they are responsible for notifying the doctor, patient, or both, and recommend potential alternatives.
This specific skill of pharmacists makes them desirable in clinical research industry. Their knowledge is very helpful in documenting any adverse event related or not related to the drug during the conduct of a trial.
Let’s take a deeper look at how pharmacists fit into clinical research:
Pharmacy Graduates have an added advantage:
As mentioned, a pharmacy graduate has a better understanding of the medical and scientific terminologies used in the pharmaceutical research industry and hence has an edge over other graduates entering the field.
Additionally a pharmacy candidate can understand the importance of any drug-drug interaction, variation in dosing schedule and problem told by a patient. He/she thus proves to be a helping hand in drug development and research process, working along with clinical investigator in proper execution of the trial or working with a sponsor in development of clinical protocol.
Getting a Good start:
Most of the pharmacists start their career dispensing pills at a local pharmacy. Some pharmacists also become directors and part of a new product development at various pharmaceutical companies distributing experimental drugs for clinical trials. In essence, pharmacists help coordinate the research and development process that brings new medication from the laboratory to the familiar pharmacist shelf.
Career Opportunities for Pharmacists in Clinical Research:
Clinical Research Coordinator/ Clinical Research Associate
An entry level to most of the pharmacy graduates to enter into the clinical research industry is as Clinical Research Coordinator or Clinical Research Associate.
A clinical research coordinator (CRC) is the person who works under immediate direction of an investigator who is conducting a trial at a trial site; mainly hospital, private clinics or any institute. CRCs are considered as the vital part of the clinical research process because they are involved in the data generation process which on a later stage is evaluated for safety and efficacy of the product being investigated. As they have basic understanding of the terms and codes used by a physician, pharmacists as CRCs can generate data and it is later transcribed in the case report form.
A Clinical Research Associate (CRA) is the person who monitors the activities conducted by CRC and investigator and checks its compliance with the written set of guidelines which are Protocol, SOP, GCPs and other regulatory requirements. While a CRC helps in data generation, a CRA is the person who checks this data for its credibility to be evaluated on regular basis. A CRA needs managerial capabilities, should be well-versed with the research needs, understand the trial related activities, and plays a dynamic role in developing interpersonal relationships between a site CRC, investigator and other members of the work area.
Project manager/ Research Officers
With the experience and knowledge in clinical research, pharmacy graduates can attain a managerial level within the organization as Project Managers, to look after all the trial related activities on regular intervals on the basis of the report provided to them by these clinical research associates. In addition, project managers also help in selecting the investigator in conjunction with the CRA, collect and analyze trial data, reports adverse events to regulatory bodies or sponsors, write and publish trial study report. They also ensure that all trial related activities are completed within the designated timeframe hence reaching milestones that have been set.
Some of the pharmacists may become Research officers who help in writing the trial protocol for the pharmaceutical companies.
In addition, a number of pharmacists work as consultants for biotechnology or small pharmaceutical companies that have a promising compound and are trying to design the first clinical protocol testing the compound's safety in human subjects. As these companies need to think through questions like 'What is the appropriate dose? What is the toxicology profile?', pharmacists provide the right answers because of their knowledge and experience.
An experienced CRA with a pharmacy background can choose his/her career as an auditor. An auditor is someone who monitors all the activities of the CRA and trial related documents to ensure that compliance of in the trial is maintained. An Auditor also helps by analyzing errors and in rectifying them.
Drug Safety Specialist
Collecting all the data related to the safety of the drug, such as adverse events, serious adverse events, unexpected drug reactions and compiling them to evaluate the safety profile of the investigational product is a job that can only be performed by a medical candidate or a person with knowledge in pharmacology. Drug Safety Specialists typically scrutinize reports obtained from all the sources (Sites) for their validity, whether or not they are related to the investigational product, outcome of that event and many more.
Clinical Data Management (CDM)
Clinical Data management has now come up with new dimension in clinical research for most of the graduates regardless of their majors. One can also explore his career in CDM at various positions like Data Entry Associate, Data base designer, programmer and many more.
Even in Contract Research Organizations (CROs), there are separate pharmacies to store and dispense investigational drugs that are to be used at trial sites. A pharmacist with knowledge of clinical research has to have understanding of the research activities and the need. Storage of investigational product is essential to the protocol and storage instructions. Maintenance of dispensing logs and accountability of test product can only be done by a pharmacist.
Pharmacists with advanced training may also collaborate with other providers to focus on direct patient care activities. These activities may include policy development or clinical research rather than reviewing and approving prescription orders.
It is thus clear that clinical research offers tremendous opportunities and possibilities for pharmacy graduates. The key for anyone looking to enter into clinical research is to find the right strategic partner to undergo the training, seek internships/projects in clinical research to determine the fit better and network within the industry.
Dr. Sumit has extensive experience in training and research and development in clinical research. He currently manages clinical research operations at Clinical Research Academy of America (CRAA) a leading provider of training and internships in clinical research. For more information, please visit www.clinacademy.com