Staff Your Clinical Research Study
The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
An essential step in clinical research, after you've secured funding and established the parameters of your project, is organizing a staff that will enable you to conduct the study. If you're already working in a clinical setting, you'll most likely have a staff of health care professionals and administrators to assist you with patients. However, if you don't have access to these resources, you'll need to carefully consider your staffing needs. The first step is to determine the type of staff you need.
What does a Research Coordinator do?
The duties of a research coordinator may include:
- Serve as a liaison between the sponsor/CRO, PI, patients and IRB
- Submit regulatory documents, revisions and renewals to the IRB
- Advertise for, screen, consent, enroll, and randomize patients
- Schedule patient visits and tests
- Conduct study visits with patients
- Track and document adverse events
- Compile source documents
- Fill out required logs and case report forms
- Follow GCP (good clinical practices) and ICH (International Conference on Harmonization) guidelines for research on human subjects
- Communicate effectively with the study team to address queries
- Attend investigator meetings and coordinate monitoring visits
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 a research nurse.
Do you need a research coordinator or data manager?
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. Research coordinators can also help with management of the Regulatory Binder and consenting of patients for less medically complex protocols. Some research coordinators have phlebotomy certificates which allows them to help with blood draws if needed.
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. Ensuring that your study is compliant with FDA 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. This may mean you need a research nurse, a research coordinator and a data manager.
Decision tree to help investigators in hiring research staff
Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100).
The following skills are necessary to help you with your protocol management depending on the complexity of your research protocol and subjects. These will ensure that your study is managed effectively with emphasis on the safety and follow up of your subjects as well as managing the protocol to the highest standard per ICH and GCP guidelines.
- Critical Decision Skills
- Protocol Management
- Subject Safety
- AE management
- Knowledge Base
- AE management
- Subject follow up
- Extraction and Analyzation and Interpretation of Information/Data
- AE reporting
- Management of abnormal values, etc.
- Source documentation and CRF completion
To help you determine what experience and training your coordinator should have, it is important that you have an understanding of the protocol. The following subject headings will provide you with some guidance to determine the level of complexity that is required based on your subject population and what is being studied.
- Protocol Complexity
- Is the Protocol an IND or IDE?
- Will subjects be consented during routine clinic visits?
- Does the protocol require multiple follow up visits?
- Will there be an outside resource used for study related procedures
- Are there any procedures that require a licensed nurse?
- Do the follow up clinic visits require interventions, i.e. vital signs, wound care, lab draws, and study medication administration?
- Are there multiple protocol related procedures, i.e. labs, EKG, radiology etc
- Subject Population
- Healthy volunteers
- Rare disease
- Multiple co-morbidities
- Newly diagnosed disease process
- Are these subjects with existing chronic illnesses?
- Are these subjects enrolled in a critical care setting, i.e. ICU/ED
- What is the emotional status of subject during recruitment and consent process?
- Age of subject
Location for Study Conduct
- Subjects residence
- Clinic or outpatient Dept
- Clinical Research Unit (CTRU)
- CRC or PI office
- In patient unit
- Medical or Surgical floor
- Step down monitored unit
- Will screening and followup require communication with:
- multiple clinicians and other health care providers
- Outside services and providers
- Other departments related to clinical care
- Other departments within institution related to research administration
- Multiple sponsor related services, i.e. IVRS, Coordinating Center, CRO, etc.
Education and Communication
- Will the protocol require other health care providers to receive education/in-service?
- Will the subject require subject education for compliance of protocol
- Same list as above under Coordination
Resources for Finding a Coordinator
Spectrum has an email list of experienced university staff interested in part-time and full-time work. If you have a job posting that you would like us to distribute to our email list please contact Spectrum OTC.
Resources for Child Health
Spectrum Child Health offers coordinator and nursing services for child health studies. Please e-mail Mary Chen or phone 736-9783 for more information.
Spectrum periodically circulates information about new openings in clinical research to a self-identified pool of external job-seekers, as well as to our internal research coordinator pool. From time to time, Spectrum is contacted by faculty and department administrators to distribute open clinical research employment opportunities to our database.
Subscribe to the Spectrum OTC email list
If you would like to be added to our e-mail list, please send your information to: Spectrum OTC This is an informal service, intended only to be a supplement to the official University job posting process through the Stanford University Human Resources Office.