Staffing needs for research projects in clinical settings vary greatly and will be determined by the kind of study you’re running, what its demands are, and who you can afford to hire. Keep in mind that you’ll have to balance your staffing needs with your budget and that it’s never good to shortchange yourself in terms of staffing. Here are some basic questions to consider when developing a roster of positions to fill:
- Do you need a registered nurse? For many clinical studies, having an RN on staff is essential because you’ll need someone with a solid health care background who can perform some medical procedures. If your research project involves an experimental drug or medical device, you’ll need someone who can watch for possible adverse events and who is knowledgeable about the risks and benefits to the study participants. You’ll also need someone who can communicate effectively with participants and be able to explain or discuss the nature of the study with someone who doesn’t have a medical background. In some cases, a licensed practical nurse, someone with medical training, or someone with research experience might suffice, but to independently monitor and assess study participants, you’ll need an RN.
- Do you need a nurse practitioner? Depending on the nature of the clinical research, you might need to investigate hiring such a person, who would be qualified to work independently and undertake such duties as administering an IV or prescribing some medications.
- Do you need specialized staff members? Again, the answer depends on the nature of your research. For instance, there could be cases where a physical therapist or physical therapist assistant would be an invaluable asset.
- Do you need a research coordinator or data manager? If you can afford one, a research coordinator or a data manager can be very helpful additions to your staff. While a data manager can assist in maintaining data records and ensuring continuity in data collection, a research coordinator can provide valuable assistance in recruiting and screening study participants or in carrying out certain elements of the research project. For information about the kinds of responsibilities that might be delegated to someone in this position, see Typical Duties of a Research Coordinator. CTSI offers a research coordinator orientation program as well as one-on-one training.
- Are there special staffing considerations for a very large project? If you’re conducting a large clinical research project or find yourself in an especially large clinical setting, you might want to hire staff members specifically to handle regulatory work and clinical coordination. For instance, ensuring that your study is compliant with Institutional Review Board (IRB) regulations throughout the project and that IRB submissions are handled properly and on time can be demanding, especially in the case of a large study. Having a person designated to handle such tasks can be a major benefit. (For more information, see Human Subjects Research Projects.) Likewise, if you’re working with a large number of study participants, a clinical coordinator can provide invaluable assistance in organizing and dealing with participant-related issues.
For assistance in determining your clinical research staffing needs, be they large or small, you can consult one of the CTSI research facilitators.
