Clinical research professionals play a vital role in advancing medical knowledge and improving patient care through their tireless efforts in conducting clinical trials. These dedicated individuals work behind the scenes to ensure that new treatments, medications, and medical devices are safe and effective before they become available to the public. In this article, we will explore a typical day in the life of a clinical research professional.
The day before: Planning
Conducting a clinical trial requires meticulous planning, and even more so when you conduct multiple studies at once. As a clinical research professional it is best practice to start prepping the day before to ensure smooth operations for the upcoming day to help you keep track of multiple participants taking part in the various studies that are all at different stages in the life cycle. Some may be in the recruitment stage, some in the enrolment and treatment stage and others in the follow up stage or closing. Each stage requires different procedures and attention to detail. You need to take into account the amount of overall visits that will be conducted at the site on one given day, to properly plan for resources and manage your time.
You need to ensure the correct amount of approved versions of the various informed consent forms in all languages are on site for every study, that enough investigational product is on site, all the laboratory kits for the various studies and various types of samples to be collected are ready, the source templates are ready and everyone is aware of their role and what is expected of them for the day ahead.
The Early Mornings: Preparation
Bright and early, clinical research professionals begin their day by familiarising themselves again with their schedules and prioritizing tasks. They check emails, respond to inquiries from the recruitment team and study participants, and coordinate with other team members to ensure seamless communication and collaboration. Mornings may often involve meetings with principal investigators, study coordinators, and data managers to discuss the progress of ongoing studies, address any concerns, and double check their preparation of the previous day and plan for upcoming milestones.
Before diving into the day’s activities, researchers meticulously review the visit schedules pertaining to each study protocol, ensuring that every aspect of the research is conducted according to the highest scientific and ethical standards. They double-check inclusion and exclusion criteria for each study, verify that informed consent forms for all studies are up to date and available, and ensure that all necessary supplies and equipment are ready for the day’s activities.
The Mid-mornings : Participant Interactions and Data Collection
As the day progresses, clinical research professionals need to shift their focus between the various stages of the various studies. For new studies starting the focus will be on participant interaction. They welcome individuals who have volunteered to take part in the research, guiding them through the informed consent process and answering any questions they may have. Building trust and rapport with participants is crucial, as it fosters a sense of comfort and encourages open communication throughout the study.
In these startup stages of studies the researchers obtain a thorough medical history from each participant who signed consent. They will also perform various assessments, collect various samples, administer questionnaires, and perform necessary tests or procedures as outlined in the study protocol. They pay close attention to detail, ensuring that all data is accurately recorded and verified as it is during this stage where eligibility is assessed to determine if a participant can be included/enrolled in the trial. For studies where the participants are already enrolled , the emphasis shifts to administering investigational treatments or monitoring participants for any adverse events as well as efficient and accurate data collection. Researchers adhere strictly to the study protocol, ensuring that each participant’svisit follows the predetermined schedule and procedures. They navigate through assessments, questionnaires, and tests, capturing the information that will later be analyzed to draw meaningful conclusions.
For studies in the follow up stage or ready to close the researchers focus is on ensuring the database is complete and no outstanding queries in the system, performing last assessments and resolving previously reported adverse events and deviations and ensuring every tablet received and dispensed can be accounted for.
Time management is key, as researchers must balance the need for thorough data collection with the importance of maintaining a comfortable and positive experience for participants. They remain vigilant, monitoring for any adverse events or deviations from the protocol, and promptly address any issues that arise. As the day progresses, researchers meticulously document each interaction, guaranteeing a complete and reliable dataset that will form the foundation for future analyses and insights.
Afternoons: Quality Control, Data Management and Admin
In the later half of the day, clinical researchers turn their attention to internal quality control checks, data capturing and administrative tasks. Internal quality control, where they carefully review the day’s work and all the data entries made in each participant’s study binder to ensure there are no open fields, missed procedures or incorrect documentation to enable the team to enter collected data into electronic databases, double-checking for accuracy and completeness. Data cleaning also forms part of these activities where queries raised by the monitor, during a prior visit, are addressed.They communicate and work closely with the clinical research associate to identify trends, patterns, and potential areas of concern.
The clinical research professional needs to ensure their administration around each study stays up to date by filing all newly signed informed consents, laboratory requisition forms, study logs and lab reports in each participant binder after their review and sign-off. .
In addition to quality checks, data management and filing, afternoons may involve reporting new adverse events or protocol deviations to sponsors, Research Ethics Committees (RECs), and other regulatory bodies, investigating the root causes of repetitive or major deviations and discussing corrective actions and preventive actions to implement as a team. Researchers diligently document every aspect of the study, from participant recruitment and enrollment to adverse event reporting and protocol deviations – all leaving a crucial audit trail – telling the story of each participant’s journey on the study from start to end. These documentation serve as critical evidence of the study’s adherence to good clinical practice, ethical and scientific standards.
Evenings: Continuing Education and Professional Development
Clinical researchers often dedicate time to their own professional development. They stay up to date with the latest advancements in their field by attending webinars, participating in online courses, and engaging with professional organisations. Keeping abreast of new technologies, methodologies, and best practices is essential for maintaining a competitive edge and ensuring the highest quality of research.
Researchers may also use evenings to catch up on emails, reading scientific journals, reviewing literature related to their ongoing studies, and exploring potential avenues for future research. They engage in discussions with colleagues, sharing insights and ideas that can lead to new approaches and collaborations.
Beyond the Daily Grind: The Impact of Clinical Research
While the day-to-day responsibilities of clinical researchers may seem mundane at times, the impact of their work cannot be overstated. Every data point collected, every participant interaction, and every report generated contributes to the advancement of medical knowledge and the improvement of patient care.
Clinical researchers play a vital role in bringing new drugs, devices, and interventions to market, offering hope to individuals battling various health conditions. They help identify safer and more effective treatments, reduce the burden of disease, and ultimately, save lives.
Moreover, clinical researchers serve as advocates for study participants, ensuring that their rights and well-being are protected throughout the research process. They act as a bridge between the scientific community and the general public, fostering trust and promoting the importance of clinical research in shaping the future of healthcare.
A day in the life of a clinical researcher is filled with a diverse array of tasks, challenges, and opportunities. From the early mornings spent planning and preparing to the late evenings dedicated to professional development, these dedicated professionals work tirelessly to advance medical knowledge and improve patient outcomes. Through their unwavering commitment to scientific rigour, ethical integrity, and patient care, clinical researchers continue to push the boundaries of what is possible in the world of healthcare.
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