Clinical trials are when researchers study a behavioral, medical, or surgical intervention on people to determine its safety and effectiveness. Trials can be focused on medications, medical devices, vaccines, or diets. They are essential to identify ways to enhance current treatments, determine if side effects are within acceptable limits, improve care for future patients, advance medical knowledge, and so much more.
Staffing for a clinical trial can be challenging, with so many specialized positions to fill, including biostatisticians, investigators, regulatory affairs experts, and researchers. But before you even begin to recruit individual talent, you must view the trial through a wide lens, and begin to understand how broad factors might affect your staffing efforts.
Here are the most important factors to keep in mind:
Study Size and Complexity
Enrolling an adequate number of participants is essential to obtain reliable data and results, draw accurate conclusions, and extrapolate findings to the wider population. Large, complex, and multicenter trials may require more staff.
Study Location(s)
Study location(s) can include hospitals, clinics, and government, nonprofit, or private sites. They should have essential capabilities to conduct trials, particularly the required number of staff, patient pool, and adequate space for studies, drugs, devices, documents, and equipment.
Study Timeline and Duration
The study timeline and duration depend on the trial type and phase and can span months to years. Correctly estimating the required number of sites, timelines, and duration can result in complete trials, sufficient data, and study success.
Study Budget
Clinical trials cost millions of dollars. Funding will only be granted if the proposed budget is reasonable. Funding is primarily allocated based on the number of participants, number of procedures, and study type, size, location(s), and duration. Other considerations include startup fees, patient care, personnel salaries, data collection, and site costs. Although budgets, including administrative costs, can be negotiated with sponsors, pricing is competitive.
Required Expertise and Qualifications
All staff should possess the requisite credentials necessary for their specific roles. Principal investigators, medical monitors, and physicians should be licensed medical doctors. Research nurses should also be licensed. Other staff should possess advanced medical, health, or science degrees. Senior staff should preferably be experienced in clinical research.
Regulatory Requirements
In this highly regulated space, requirements include obtaining necessary approvals from IRBs, government, and health authorities on the use of human participants and regulated products.
Only after all of these factors are considered can a hiring strategy be put in place. Understanding the details behind each of these factors will help you recruit and hire more effectively, increasing the chances you land the talent you need for a successful clinical trial.
To learn more about sustainable staffing strategies, get our full guide: “The Current State of Clinical Trial Staffing and Sustainable Staffing Strategies.”