Clinical research skills and knowledge are a great tool for those in entry-level medical jobs hoping to advance their career or simply gain more extensive knowledge into healthcare. If you're a nurse, phlebotomist, pharmacy technician, dental assistant/ hygienist, physicians assistant, nurse practitioner, or in a similar profession, clinical research can broaden your horizons and open new avenues of employement such as:
- Clinical Research (Clinical Operations) or Clinical Research Assistant – Individuals who work in clinical operations generally work with the design, initiation, conduct, and follow up of clinical trials. These individuals may work for the Pharma/Device/Biotech company or contract research organization (CRO) or the research site.
- Pharmaceutical/Device/Biotechnology company, or contract research organization (CRO) – CROs are companies who support the work of the Pharmaceutical/Device /Biotechnology companies. Many individuals get their first jobs with a CRO and it is important to get this kind of experience. These individuals interact with the research sites and work with the data. Positions include (but are not limited to) research assistants, clinical research associates (CRA), regulatory associates, site start-up specialists, project managers etc. They perform many functions including investigator selection, review and maintenance of study documents, ensure the accuracy of the data, ensure the adequate conduct of the trial according to federal regulations, correspond with research sites etc.
- Research Sites (hospital, academic medical center, independent research site) are where the clinical trial is generally conducted. Positions available may include that of a research assistant, study coordinator, or clinical research associate. These individuals work with the clinical trial participants and generally assist in collecting clinical trial data.
- Clinical Data Management –Individuals working in clinical data management generally obtain the data collected during a clinical research study and is responsible for entering it into a database, correcting and “cleaning” the data by querying the research site and assisting with verification and analysis of the data. Common positions include data assistants or data managers.
- Regulatory Affairs –Clinical research is a highly regulated industry. The work of clinical research professionals must be conducted in compliance with many rules based on federal laws. Many companies have a department that handles the regulatory aspects of the clinical trial, and for the entire development program for the product that is being studied. Individuals working in this area may interact with the FDA and other regulatory agencies, ensuring that all trials are conducted according to FDA specifications, working with study documents and marketing applications.
- Product Safety/Pharmacovigilance –Individuals working with product safety/pharmacovigilance may be responsible for working with the safety information that is learned about a product. Clinical research includes obtaining information about “adverse events”; this information must be reviewed to ensure its accuracy. Any errors and “gaps” in the information must be resolved. This information is consolidated, analyzed and becomes an important part of an application to gain marketing approval of a product. Positions in this area generally require some medical background such as nursing and may require clinical research experience.
- Quality Assurance/Auditing –Individuals working with quality assurance and auditing ensure that all research activities are conducted in accordance with applicable FDA regulations, guidelines, clinical trial specifications etc. This is accomplished by performing independent reviews of various aspects of clinical trials. These positions often require clinical research experience and special training.
- Medical Writing – This area prepares multiple documents required for clinical research. These documents might include clinical research protocols, study reports, safety narratives and reports or regulatory submissions to the FDA or other agencies. Positions in this area generally require experience and specialized training.
The Foundations of Clinical Research program at PCC Institute for Health Professionals will prepare you for the above mentioned career opportunities and more. The program is both live-taught and online in order to accomodate any student.