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Summary
Building trust between clinical research associates (CRAs) and study teams is all about creating a strong, collaborative relationship where both sides communicate clearly, respect each other's expertise, and work together to solve problems during clinical trials. This foundation helps research run smoothly, supports better patient outcomes, and makes it easier to tackle challenges as a team.
Encourage open communication: Make it a priority to create a space where everyone feels comfortable sharing concerns, asking questions, and discussing challenges that come up during the study.
Show mutual respect: Acknowledge the experience and valuable insights of each team member, and always consider their workload and perspectives before making requests or decisions.
Collaborate on solutions: Work together to address any obstacles by sharing information honestly and brainstorming practical steps to keep the research moving forward.
Site selection visit yesterday reminded me why experience trumps technology
Rare rheumatology trial, complex protocol, new CRA to our site
What I expected: 3-hour presentation covering every protocol detail, standard feasibility questions, generic site capability review
What actually happened:
CRA walked in and said: ‘You’ve been doing rheumatology trials for 8 years. Let me tell you what’s different about this one and what might trip you up.’
Next 45 minutes:
• Highlighted 3 specific inclusion criteria that look straightforward but aren’t
• Explained the one procedure that sites consistently struggle with
• Shared what the successful sites do differently
• Asked pointed questions about our patient population patterns
No fancy PowerPoint. Just relevant intelligence. Sometimes the best technology is just human expertise applied thoughtfully.
Why this still works in 2025:
• Saved 2+ hours of irrelevant information
• Built confidence in the sponsor team
• Focused on actual operational challenges
• Respected our experience while sharing critical details
The takeaway: Good CRAs don’t follow scripts. They adapt to site sophistication and focus on what actually matters.
Old school? Maybe. Effective? Absolutely
I post clinical research backed data to help you live better and longer |SUPM| Speaker | Consultant | Author, “How to Snag that First” Series, ICH GCP E6 (R3), Mastering Clinical Trials on Amazon|
🔍 Uncovering Hidden Site Challenges at the SIV! 🔍
As CRAs, we ensure the smooth execution of clinical trials and guarantee the integrity of data collected at investigational sites.
During SIVs, we strive to help the sites establish a solid foundation for the trial. However, sometimes, sites may not fully recognize or disclose certain obstacles they might face. Unearthing these hidden challenges is crucial to proactively addressing potential issues, supporting the site, and maintaining the trial's success.
Here are some tips and strategies to help our CRAs uncover those elusive obstacles:
✅Establish Open Communication: Foster a supportive and trusting relationship with the site staff from the outset. Encourage open communication channels so they feel comfortable discussing any challenges they might be experiencing. Dive deeply into each topic on the SIV slides and discuss them individually to identify any potential roadblocks to site recruitment/enrollment.
✅Ask Probing Questions: Go beyond the standard checklist during the SIV. Ask thoughtful and detailed questions about their processes, resources, staffing capabilities, and prior experiences to identify potential red flags.
✅ Listen Actively: Listen closely to verbal and non-verbal signals during conversations. Sometimes, sites may indirectly hint at underlying challenges without explicitly stating them.
✅Review Previous Data: Analyze the site's historical data and performance from similar previous trials to spot recurring issues hindering their efficiency.
✅ Engage with Multiple Staff Members: Speak with various team members involved in the trial's conduct. Different perspectives might reveal unique challenges faced by other roles within the site.
✅Observe Site Operations: During your visit, observe the site's operations. Witnessing their processes firsthand can provide insights into potential inefficiencies or resource constraints.
✅Compare Site Metrics: Benchmark the site's metrics against similar sites in the past to identify any potential issues or areas of improvement.
✅ Network with Other CRAs: Connect with fellow CRAs to share experiences and learn from each other's insights. They may provide valuable advice on detecting hidden challenges.
✅Support and Offer Solutions: When you do uncover hidden obstacles, be proactive in offering support and collaborative solutions. A problem-solving approach can strengthen the site's confidence in overcoming challenges.
As CRAs, we play a pivotal role in ensuring the success of the sites and clinical trials. By employing these strategies, we can better equip ourselves to detect and tackle hidden site challenges, support our sites, and drive toward more efficient and successful trial execution.
#ClinicalResearch#CRALife#SiteInitiation#ClinicalTrials#clinicalmonitoring#HowtoSnagThatFirstCRAjob
CRA + CRC = Study Success
One of the most overlooked but critical factors in a trial’s success is the strength of the relationship between the CRA and CRC.
When communication flows smoothly:
• Site issues are resolved faster
• Queries are answered promptly
• Protocol deviations are minimized
• The patient experience improves
But when there’s a breakdown in communication?
Delays, misunderstandings, and frustration for everyone involved.
Here’s what works:
• Set clear expectations from Day 1
• Respect each other’s time and workload
• Use regular check-ins, not just monitor visits
• Approach challenges as a team not as opposing sides
At the end of the day, both the CRA and CRC want the same thing: a well-run, compliant, and patient centered trial.
Mutual respect + clear communication = better research.
Let’s keep building bridges across the sponsor site gap.