Lead clinical research coordinators are in charge of overseeing staff on a clinical research team with the goal of ensuring efficiency and productivity. Clinical research involves creating studies that evaluate the effectiveness and safety of certain medications by performing trials on a large group of human participants. As clinical trials can be performed by a variety of organizations, clinical data managers have a wide range of prospective employers; they could be employed by governmental agencies, pharmaceutical companies, universities, or independent researchers, among others.
The lead clinical research coordinator is primarily focused on managing the clinical research team as a whole, including ensuring staff are following all relevant regulations and professional ethical standards. They may also be responsible for hiring and training for new staff members, as well as creating new documents, procedures, and systems. Their work is largely indoors and usually takes place during regular business hours. They liaise frequently with colleagues on the clinical research team and may report to a research manager or other manager in their organization.
Lead clinical research coordinators generally must have a bachelor's degree in a related scientific discipline, as well as relevant experience; some organizations may require or prefer a master's degree. Required skills for lead clinical research coordinators include a comprehensive understanding of relevant computer systems and databases, good written communication skills, a thorough knowledge of Food and Drug Administration (FDA) regulations and relevant best practices, and excellent interpersonal and organizational skills.
Lead Clinical Research Coordinator Tasks
Obtain and maintain informed consent of research subjects or their guardians.
Handle and review clinical trial processes and ethics compliance.
Compile, organize and submit institutional review board documentation.
Leads team in clinical research study activities.
Report side effects and safety findings from drug trials or testing.