Managing a clinical research site can be a very rewarding but often very stressful position-- especially when you are sandwiched between the needs of your direct reports and the needs of the company. While there is no perfect formula for running a successful research site, there are a few things you can do as the clinical trial manager to ensure everything runs as smoothly as possible. Hiring exceptional employees, acquiring experienced primary investigators with robust subject databases, and providing quality research data are three of the most valuable assets you can acquire to provide exceptional work and in turn, exceptional profit for your site.
Perhaps the most important advice for running any business is to hire quality employees. Depending on the size of your organization, you may have a dedicated HR department to screen candidates or perhaps outsource screening to a recruitment company. If you run a smaller clinical trial site, you may be responsible for all steps of the hiring process. Either way, ensuring that the employees you hire for your company fit the company culture and expectations is key. Also ensuring that you have adequate coverage of your clinic is crucial to the success of your team. You should have a solid understanding of how much work one person can handle and provide support to your employees to keep burnout at bay.
Clinical research is a very unique industry and it can be very difficult to find qualified employees that work with your site's budget, so it is important to know what skills can be taught and what skills are innate. Finding an employee with a strong desire to learn, a dedicated work ethic, and the ability to take on multiple tasks throughout the day can be worth more than finding an employee who has previous research experience. GCP, IATA, and SOPs can be taught internally, so while they are important to the position in general, they are not necessarily a requirement for a new hire. What it all comes down to for hiring exceptional employees- hire for attitude and aptitude, and you can train for skill.
While the above is solid advice for the employees in your site, having an experienced physician to be the Principal Investigator for your site is worth its weight in gold. Ideally the PI(s) at your site will have extensive knowledge not only of the indication they are working on, but also in the responsibilities required for an investigator. This means they should truly understand and respect the amount of time and effort it takes to properly run a clinical trial. They should have a good grasp on ICH-GCP requirements for running the trial, including who to delegate tasks to, what counts as proper oversight of the trial, and how to assess adverse events that come up during the study. A physician who is new to research should work as a Sub-Investigator under an experienced PI who can mentor them until they are ready to conduct studies of their own.
Another important quality your physician should bring to the table is potential subjects. Ideally, they will have their own practice to pool subjects from or be in a multi-physician practice with a large database you can access. They should be willing and able to speak about research with their colleagues about potential referrals and the importance of research in health care. You want your physicians working for your trial site-- that means more than just seeing subjects already enrolled in trials. A strong PI should be able to bring a wealth of information, contacts, and support to your team.
Finally, as site director, you want to ensure that your site is providing top quality work for sponsors. Fast, efficient data is crucial in bending the time-cost curve of research and it all starts at the site level. You want to ensure your site has strong, audit-tested SOPs in place that actually reflect the way the work is completed on a daily basis. There are many great resources on writing excellent SOPs, some companies even provide templates for them, but you want to make sure they are tailored to the needs and set up of your research site. Once the SOPs have been drafted, you will need to make sure all of your staff is adequately trained on them and understand the importance of following them during their everyday tasks. You will also want to review regularly--typically annually-- to ensure that they are still feasible and meet any changes to regulations in the industry.
It is important to ensure your staff is adequately supported so that they can produce quality work. Hiring the right people for your company's culture and expectations is by the most important thing you can do as the leader of your team. Ensuring you have enough employees to handle to demands of the workload is also incredibly important. Working with physicians who bring more to the table than just their title can make a world of difference in your site's ability to be successful. Bringing it all together with strong operating procedures and high standards of care will ensure that your clinical trial site is slated for success!
Eleanor (Ellie) Houston has been a clinical research professional for 9 years. She has worked as a CCRC, a research site manager, a Quality Assurance Officer, and currently as a CRA. She was also named Clinical Researcher of the Year- New CRA at the 2018 CROY awards last spring.