Quality clinical trials couldn’t happen without clinical research coordinators (CRCs). At the site level, the burden of the responsibilities for conducting clinical trials ends up on the shoulders of coordinators. CRCs are behind the scenes, making trials happen by managing various aspects of trial management, regulatory compliance, data management, drug safety, recruitment, and administrative tasks. With the growing list of crucial responsibilities CRCs oversee, it is no surprise that turnover is such a rampant problem in the industry.The fast pace and full plate of coordinating can be a challenging, yet rewarding position if coordinators feel adequately trained and supported. Without the proper training and supports in place, coordinators are at risk for burnout and turnover. Not only will management have to expend resources to hire a replacement when a coordinator burns out, but overworked coordinators are more prone to costly slip-ups that could endanger the safety and bottom line of studies they're managing. Strained coordinators can't safely and effectively manage the trials they've been assigned.
CRCs have to know the protocol inside and out, and walk patients through the entire process of participating in trials, including recruitment, scheduling, screening, study visits, and follow-up. They are constantly collecting and meticulously recording clinical data, and ensuring GCP-ICH compliance in all areas. In some cases, coordinators are even looped into marketing, business development, and financial matters.
Burnout from heavy workload is a leading reason behind the problematic turnover rate of clinical research coordinators. In a study written by Clement K. Gwede, PhD, MPH, RN from Moffit Cancer Center, 70% of research coordinators would still choose the research industry. We know burnout is prevalent in CRCs, but many of the cases go undocumented. This study, Burnout in Clinical Research Coordinators in the United States, found the biggest reasons for burnout are due to "job dissatisfaction, perceived daily work overload, low endurance, and nurturance personality traits."
Site management should take steps to alleviate those pain points. Experienced, motivated clinical research coordinators can give research sites a competitive advantage. These are our tips for maintaining happier and more qualified clinical research coordinators on your team.
1) Start with comprehensive training.
Clinical research coordinators often learn their jobs as they go. Other than the general GPC and CRC courses, these trainings are tedious and only apply to the day-to-day job. In any industry, it is important to keep staff motivated by investing in other courses that may not seem directly relevant to the day-to-day job but will improve professional growth. Providing education, training, and support in order for CRCs to successfully meet the study responsibilities placed upon them will have a higher return on investment because happy employees are more productive.
2) Pave the way for upward mobility.
Investing in professional growth helps motivate employees and makes them feel like a valuable part of the team. Send your coordinators to events that will further their professional development, like industry conferences and meetings. Not only will they come back from these events with new connections and knowledge that may benefit the site, but it's also a strong way to demonstrate how you are truly invested in their professional growth.
3) Paint the bigger picture.
Among the hectic day-to-day at a site, it can be easy to lose focus of the bigger goal of clinical research - advancing the future of medicine. All of the work done at research sites, even the tedious paperwork and data collection, is contributing to a better, healthier tomorrow. Make your organization’s mission well-known, as well as each team member’s role they play in furthering that mission.
4) Implement CTMS to streamline operations.
CTMS can automate several daily tasks for CRCs, streamlining their workflow. Transitioning your efforts from paper files and manual data entry may sound like a big investment, but consider the efficiency and savings that apply in a long-term success of your site. CTMS usually tracks patient recruitment tactics, monitoring lead generation, prescreening, and randomization status, which allows you to easily report your recruitment ROI to sponsors.
If you are looking to centralize many of your manual efforts, do your research and review which CTMS platform will have the most seamless transition from your current process. Our partner company, RealTime-CTMS works with our network of sites to help us track patients throughout the clinical trial process. RealTime-CTMS is designed to provide quick and easy access to study or subject information utilizing simple and intuitive navigation.
While it may seem efficient to have employees who can wear many hats, this can result in a "too many cooks in the kitchen" situation. Providing basic training in areas like marketing to your staff is great when your team is low on resources and need to step in, but having dedicated specialists who can take the lead allows for a team to run more smoothly. Limit the number of hats a coordinator has to wear by outsourcing certain aspects to experts. Hire administrative staff to assist with the phones, data entry, and to schedule and track patient visits. Contract advertising specialists for recruitment campaigns and a business development team to bolster your pipeline and connect you with sponsors. You'll get a professional service from experts and leave your coordinators more time to focus on their main objective - safely and effectively managing trials and care of patients.
Source: ONCOLOGY NURSING FORUM – VOL 32, NO 6, 2005 1129