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Building a Team

Sponsors should be hands on from the beginning when choosing their CRO team. It’s always beneficial to review resumes and phone screen prospective team members and site monitors. If possible, arrange face-to-face interviews as this is extremely important in determining compatibility, professional style, and discerning whether they would be a good fit for the project. Lastly, don’t forget to check references. It’s always easy for people to overlook this aspect, especially after meeting a candidate who appears the ideal candidate. Nevertheless, it’s vitally important sponsors vet candidates thoroughly, and that includes checking in with former employers, to determine their suitability for the role.

Once you’ve selected your team members, confirm what percentage of time that project leaders and monitors will be working on your study. Oftentimes the amount of time a person on your CRO team is obligated to work on your trial is either undefined or not specified. Always bear in mind that CRA or data monitor might be working on other studies in conjunction to yours. Therefore, defining the percentage of time they’ll commit to your study is crucial. Also, experts say having one point of contact for each role is not ideal. CRO teams should not have just one data manager or one project lead; sponsors should strive to create a wide range of team members. This is vital because turnover within a CRO is inevitable, and can disrupt your study. To mitigate that it’s more advantageous to create a team that is built with one key leader for each role. Remember, having a backup is essential.

Involve CRO from the beginning

When developing the study design and preparing for the study start-up, seek to actively engage the CRO in the process. Naturally, teamwork is important, so sponsors should strive to build a collaborative relationship. Be inclusive, create a team contact list and set up regular teleconferences where you meet with your team for updates on the trial. It’s important you integrate them from the beginning, so that in the event of a crisis, the CRO team can work with you to find a solution. Ultimately, sponsors should make the CRO an extension of its internal team, emphasise that they are not only representing their own company, but the sponsor as well. Develop a clear understanding of what is expected from the CRO. Define expectations so that ‘sense of urgency’ is aligned. Carry out recurring face-to-face meetings in addition to routine teleconferences.

Relationship Challenges

Once you’ve partnered with your CRO, define what kind of relationship you want with them moving forward. It’s important that you find synergy with your CRO, so be sure to establish your goals for the study and demonstrate your commitment toward a respectful and inclusive collaboration. Maintaining total power and control leaves little room for learning and progress. Create an environment open to suggestions. Lastly, don’t underestimate the simple act of being nice. Personality or style differences are not always a bad thing. Nevertheless, pointing the blame when something goes wrong is never a successful tactic. Remember, a negative reputation stays with you forever, so be positive and adaptable.

Be sure to develop an effective communication strategy that works best for the study. The key is clarity; don’t leave room for misinterpretation. Don’t wait till a problem occurs to escalate communication, if an issue arises, deal with the matter head on and resolve it. CRO staff turnover is inevitable, but if you team that is built with more than one key leader in each role it can be less disruptive. Lastly, if you nurture and value the relationships with your CROs, you can maximize the benefits of the services they provide.


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Jacqueline Lee, Director, Clinical Operations, Cytokinetics, Inc. – Keys to Achieving a Successful and Effective Working Relationship with your CRO… Lessons Learned (Presentation)