A day in life of Clinical Research Professional?
Clinical trials entail people with extensive knowledge and expertise to perform variety of roles. Clinical research professionals are integral part of clinical trials or studies of all kind. They are liable for designing, conducting, and managing the clinical trials. They manage, support, expedite, and organize day-to-day clinical operations and activities, supervising and performing delegated tasks. The career path of a clinical research professional consists of administrative to technical job roles. A clinical research professional can be a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Research Scientist (CRS), Biostatistician, Data Manager, Clinical Trial Analyst (CTA), Quality Auditor, Regulatory Specialist, Medical Writer, Site Monitor. Clinical research professionals may have credentials in nursing, pharmacy, medical technology, business administration, health administration and management, statistics and other allied fields. They all work together as a team, support the clinical trial process, and deliver anticipated results with high efficacy, quality and accuracy, in compliance with obligatory federal and regional regulatory requirements. They are a liaison between the sponsor and the contract research organisation.
Clinical research professionals should be sympathetic, amenable, and focused with effective communication skills. They should work cooperatively as a team with problem solving ability and make accurate and suitable decisions. Clinical researchers must be detail-oriented, well organized and scientifically sound. Clinical research professionals, especially clinical research associates and clinical research coordinators should be prepared to travel, as they have to conduct site visits throughout the country.
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Role of a clinical research professionals start from selecting the trial site to gathering and finalizing the data after completion of the study. Clinical trials takes place at a trial site, which can be a hospital, research institute or a clinic. Clinical research professional plays a key role in selecting a clinical site. They conduct site selection visits and assure that the site is well equipped with all mandatory requirements for a particular study.
As the sponsor approves the site selected by the clinical research professional, they organize the site to conduct the study as per the study protocol and sponsor’s site vitalities. They are also involved, along with the principal investigator in recruiting the study participants by means of informed consent process; they screen the volunteers in accordance with the inclusion and exclusion criteria as stated in the study protocol.
As the sponsor approves the site selected by the clinical research professional, they organize the site to conduct the study as per the study protocol and sponsor’s site vitalities. They are also involved, along with the principal investigator in recruiting the study participants by means of informed consent process; they screen the volunteers in accordance with the inclusion and exclusion criteria as stated in the study protocol.
Once the site begins, they conduct site visits at regular intervals to ensure that the study is proceeding in compliance with the protocol and other specified regulatory requirements (Good Clinical Practices) and also the participant’s rights are well preserved. Clinical researchers should ensure effective communication among different sites (in case of multicentric trials), sponsors, clinical research organizations, ethics committee personnel and regulatory authorities.
When the study ends, they should conduct a close out visit; they should gather, analyse, examine and verify all the data and all study related documents necessary to complete a final report for the study sponsor. For attaining this there should be data collection tools and methodology. The date collected should be attributable, legible, contemporaneous, original, and accurate.
To maintain data integrity, Clinical researchers designs a case report form (CRF) which describes and stipulate the type of data to be collected, the units of measurement to be used, and CRF completion guidelines (i.e., instructions for filling in data). Coded terms are used to annotate the variables. CFR tracking, data entry, validation, discrepancy management, medical coding, and database locking are following steps in the procedure.
Clinical research professionals are obligatory at every step of clinical trial procedure; they play a vivacious role in assuring the efficacy and reliability of the information collected from clinical trials.