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Clinical Research Coordinators

The Job

The work for clinical research trials starts in the laboratory, where researchers test treatments and procedures and conduct animal studies. The findings that show the most promise are used as experimental treatments in clinical trials. These trials are done in phases, with results recorded each step of the way to best determine the effectiveness as well as the risks. A protocol is then established for the clinical research trial, which spells out the types of subjects that are eligible, the details for the tests and procedures, the types and amounts of medications and dosages that will be used, and how long the study will last and the information that will be collected. The clinical research team typically includes a doctor, who is the principal investigator, and the clinical research coordinator.

Clinical research coordinators have a variety of responsibilities and play an important role in moving the research study forward. Their tasks may include analyzing the costs involved in the research trial, and researching and applying for funding for the trial. They manage the budget and make sure all costs are met. They assess and interview subjects for the trial, conducting screening interviews, reviewing medical records, and gather information from physicians and nurses. After subjects are deemed eligible, coordinators provide them with enrollment paperwork and review completed forms to make sure they are correct, the subjects understand the terms of the trial, and their consent has been documented.

Clinical research coordinators pay close attention throughout the research study, making sure that all activities are compliant with government regulations and institutional policies. They monitor subjects' health throughout the study and record data for case report forms, drug dispensation records, and regulatory forms. If an adverse event or side effect occurs during the study, they work with the primary investigator to file event reports with oversight agencies.

This type of work requires a combination of active listening, flexibility to adapt to the actions of others, strong organizational and detail-oriented skills, and clear writing and speaking for conveying information to subjects, co-workers, doctors, and other clinical research professionals. Coordinators must also be technologically savvy; they use various types of software for analysis, drug coding, patient tracking, and creating spreadsheets.