Diverse opportunities are available to pharmacists for independent work with broad range of roles in clinical research. Pharmacists use number of skills and play important role in areas of clinical trial operations, medical writing, pharmacovigilance, researchand development and medico-marketing.
Clinical Research Pharmacist
Pharmacists are on the front lines of dealing with health issues and ensuring suitable drug or therapeutic treatments. Pharmacists are given great responsibility to ensure safe pharmacological practices in pharmaceutical companies while in tandem work or associate with doctors and the public. The new compound or medicine developed in a pharmaceutical company needs to be formulated and administered to patients after establishing the efficacy and safety of the novel chemical entity in compliance with safety regulations. The packaged and labelled study drug must be carefully monitored and evaluated for unexpected outcomes or any adverse events. These pharmacists provide expert opinion on pharmaceutical aspects of the study drugs that involves assessing study methodology and design, choice of study drug, formulation and form of administration while considering possible side effects, unexpected outcomes and interactions. Pharmacists are involved in various stages of all the processes of clinical trials to ensure safety and quality of drugs.
Responsibilities of Clinical Research Pharmacist
Pharmacists working in clinical research collaborate with a wide variety of professionals including research nurses, research associates, project managers and others involved in research and development during the course of clinical trial. Pharmacists principally are involved in different areas of research and development, clinical supply, ethics committee and clinical research coordination in accordance with legislative framework and guidelines necessary for clinical trials. A pharmacist manages all aspects related to investigational study drug along with liaising with researchers to define and plan study design, identifying wide range of subject specific doses, dosage forms and training team members like clinical investigators and nurses in funding agencies and pharmaceutical companies. Clinical trial co-ordinator in hospitals and clinical research organisation require pharmacist to review the trials, explain about the drug under study, provide protocol specific instructions, train the team members and handle code break Their role involves reviewing packaging labels, storage arrangements and advocating correct use of the drugs to patients. Clinical supply pharmacists manage the manufacture, packaging and distribution of the study drug.
Courses and Training programs in Clinical Research for Pharmacists
Recent increase in clinical research and trials provide several opportunities to trained and skilled pharmacy staff. These opportunities allow clinical pharmaciststo work in government, military, private clinics, hospitals and other healthcare settings. Skills required tobecome a research pharmacistare obtained with extensive training and education programs. A research pharmacist needs to earn a pharmacy degree from an accredited institute and must be updated on latest advances in pharmacological science by continuing education courses throughout their career.
Pharmacists can apply for certificate courses to obtain advanced level of knowledge in a certain desired area of interest. These pharmacists must have communication skills to disseminate extensive knowledge acquired on the side effects of specific medicinal products and ensure safe medications by efficiently evaluating prescriptions to meet patients needs. Pharmacists need computer skills to use electronic health record (EHR) systems for ensuring accuracy in prescription delivery. Pharmacists need good managerial skills to manage inventory and oversee working of team members.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online program in Post Graduate Diploma in Clinical Research for better career options to pharmacists. JLI also provides online training in pharmacovigilance & medical writing, quality assurance, clinical dta management, regulatory affairs and medico-marketing.
For more information please visit: www.jli.edu.in