As I prepare to retire from my long and rewarding career in clinical research, I’ve reflected on key learnings to share with my amazing BRIGHT team members and fellow study monitors in the medical device industry. For the past 27 years I have worked as a site research nurse coordinator, a study lead and monitor for a large fortune 500 company, and most recently as the Monitoring Manager at BRIGHT.
The most important thing I’ve learned is the value of developing strong relationships with site research teams. They are your customers and key partners with a common goal to ensure protocol compliance, adhere to applicable regulations, and execute a successful study that puts the welfare of study subjects first. They depend on your clear instructions and use your tools to conduct studies, and ultimately, they will become primary users of the study sponsor’s medical device. As such, the sponsor and clinical research organization (CRO) must carefully consider the sites’ customer experience when planning and executing the study to ensure a great relationship between all parties and a well-conducted study.
Here are my top three tips for developing strong relationships with site research teams to ensure efficient study execution and a positive experience — for them and for you.
1. Know your audience when preparing written communications
When drafting study communications such as emails, study protocols, and other instructions, remember your audience. For example, the protocol is the recipe for conducting the study. Think about who needs to follow that recipe and who needs to audit the study to ensure the recipe was followed. This primarily includes the investigators, research coordinators, and study monitors. Clinicians are often well-versed on the clinical need, so long-winded background information on the therapeutic space and product development may be better suited for the report of prior investigations or your regulatory submissions.
The protocol should focus on describing the study design, requirements, and nitty-gritty how to. No one wants to read a 70+ page protocol that forces them to dig for subject follow-up requirements or learn later that they missed a requirement because it was buried in mountains of unnecessary text. Thoughtful indices, easy-to-find definitions, tables, figures, and flowcharts are great ways to communicate clearly and succinctly with your site research teams. Speaking of …
2. Provide clear and concise communications
Your research staff is busy. Really busy. Don’t make their eyes glaze over with lengthy, dense emails. State your request or purpose first, then support that brief “cut-to-the-chase” intro with succinct background text as needed and requested due date if applicable. Bullet lists are a great tool to help you consolidate information.
If you need to leave a voicemail, keep it brief; the recipient’s mind will wander to their waiting study subject or long to-do list when you ramble through a minute-plus message. For all forms of communication, challenge yourself to see how few words you can use to get the message across. Be sure to bring in a second set of eyes to ensure your communication is clear and doesn’t raise more questions.
3. Know the players at your site and their roles
Don’t assume your site research coordinator does everything. Find out who negotiates the contracts and budgets, prepares the IRB submissions, screens patients, consents subjects, submits invoices, follows subjects, etc. This allows you to follow up with the appropriate parties directly and not pester your crazy busy research coordinator. This may be best accomplished during the site qualification process and site initiation visit. When you get to know your customers and build strong relationships with them, you can tailor your communications to the appropriate party at the site and demonstrate that you understand their roles and what they need to know to get their study tasks done.
When you follow these three tips, you will create and cultivate great working relationships with your research teams, your sites will enjoy working with you, and you’ll benefit from a seamlessly executed study. I’ve enjoyed working with many monitors and coordinators over nearly three decades, and I hope these tips will help you enjoy a rewarding career in clinical research.