An organized clinical study requires the work of many professionals beyond the critical roles of physician and patient. Clinical studies consist of trial coordination, data processing, medical research, regulatory management, and more. Those who serve in these roles are instrumental to the clinical study’s success.
Successful clinical studies require collaboration among all team members to ensure that the trial runs smoothly and within its designated parameters.
While each clinical study has its own needs based on location, type, purpose, and design, most clinical teams include the following professionals.
The principal or primary investigator serves as the leader of the clinical study. All aspects of the study are their responsibility. Part of their role includes developing the concept of the study and composing a detailed breakdown of the proper procedures and protocols for conducting the study.
Gaining approval for the study is also the principal investigator’s responsibility. Additionally, they oversee the recruitment of participants, and they’re required to make sure that all participants understand their rights and consent to their roles in the study.
Overall, the principal investigator is responsible for developing the study’s concept, presenting the results, and every detail in between. Therefore, principal investigators need to understand the high-level science of the study. They must also ensure that the study follows all industry standards, local laws, rules, and regulations.
The sub-investigator or co-investigator role usually focuses on a single aspect of the clinical trial. Often, the sub-investigator specializes in a specific field and focuses on critical and study-related procedures and protocols relevant to their specialty.
The sub-investigator makes many critical judgments during the study and works closely with the principal investigator to make essential medical and study-related decisions on their behalf.
In studies of large size and scope, the principal investigator may need doctors to monitor and care for participants. These physicians must care for patients based on the study’s design and closely monitor and document patient responses.
The regulatory coordinator ensures that the clinical study is legal and ethical while still adhering to the framework of the study. This position is essential to the study’s safety and often provides training and guidance to team members so that everyone understands and follows the necessary standards.
In addition, the regulatory coordinator may monitor the progress of the trial or study, observing members’ conduct and keeping everything on track and within the legal and regulatory limits of the study.
The research nurse explains study details to participants and community health providers who may refer patients. In addition, they may offer clinical management expertise and work to maintain the study’s compliance with necessary regulations.
The research nurse often makes decisions regarding the clinical trial details and needs exemplary communication and organizational skills to ensure the process runs smoothly.
The study coordinator may handle recruitment, screen participants, schedule research visits, and conduct interviews. Additionally, they work closely with the principal investigator and the research institution to manage the details of the study and comply with critical regulations.
Many studies investigate the effectiveness of medications and identify side effects. Research pharmacists ensure the safe administration of all prescriptions to thoroughly test and evaluate their effectiveness.
Clinical studies can’t make innovative breakthroughs and discoveries without participants. Patients who meet the eligibility criteria of a clinical trial play a critical role in helping to diagnose, treat, prevent, and cure diseases and other illnesses.
Study participants advance medical technology and contribute to new research. In addition, clinical trials give participants access to new, cutting-edge treatments and a medical team that closely monitors their illness and overall health.
Without clinical study participants, the FDA can’t approve new, safe, and effective treatments for public use.
Orlando Clinical Research Center conducts clinical and medical research trials specializing in kidney and liver health and disease treatments. Our participants receive all their treatments and medical care associated with the study at no cost. Participants may also receive compensation for time and travel.
If you’re interested in serving an essential role in the groundbreaking research conducted during clinical trials, check out our studies to determine whether you qualify.