Managing Research Teams During COVID-19: Challenges and Strategies

This presentation discusses managing research teams during the COVID-19 pandemic, covering topics such as COVID research overview, recruitment efforts, CDC and Emory guidelines for workplace safety, rapid enrollment demands for vaccine trials, patient recruitment efforts, and staff adherence to COVID-19 guidelines. Strategies like assigning remote staff, negotiating space use, and ensuring participant and staff safety are highlighted, along with the need for rapid adaptation and effective communication within research teams to overcome challenges during these unprecedented times.

• Research Teams
• COVID-19 Challenges
• Recruitment Efforts
• Workplace Safety
• Vaccine Trials

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1. Managing Research Teams During COVID-19 PEARS: Pediatric Education Research Series Presenter- Kathy Stephens

2. Topics to cover: COVID Research Overview Challenges Learning Moments Recruitment efforts Staffing / Participant Load Time and Effort Outcome of Research

3. CDC and Emory COVID-19 Guidelines for Workplace Safety Space: Office and Clinic (ECC-RU) Assigning remote staff Participant and Staff Safety (Clinic, Eg, SR and EUH) Challenges PPE supplies Media: misinformation Personal COVID-19 Fears: Staff concerns Potential for study participants to be positive What happens to ongoing current studies? Sponsors moving quickly to design/implement COVID studies Monitors not allowed onsite

4. Rapid enrollment demands for vaccine trials Plan for Illness visits as part of efficacy (POD) Remote monitoring plans Learning Moments Negotiate use of ECC RU space. (One additional room assigned to ID) Plan for post enrollment effort/time: data entry, safety phone calls, weekly sponsor calls, queries .. Getting things done: Finding the right contacts Remote staff : not full time and without regular hours POD purchase and placement Hire temporary employees

5. Add full time recruiter and support (started with student interns/volunteers) Patient Recruitment Efforts Recruitment training: Oral HIPAA consent, Study criteria, Prescreening questionnaire per study, Practice with study lead, Schedule appointments: Goal = avoid time-intensive screen failures Use of CR assist as scheduling mechanism Know what the media is saying to anticipate questions and provide accurate responses Work with study team to establish realistic daily goals Keep the team informed about changes Make Clinic room and staff assignments

6. Staff adhere to all COVID-19 guidelines: masks, distancing, daily temps, daily symptoms Staffing Remote staff: include in planning, stay involved Weekly zoom meetings Establish responsibilities: Study supplies: staff leader Work Room Team: greeting, check in subjects (Covid screening, valet, start paperwork), study supplies in each room, assist with cleaning between visits, make/provide charts and documents, Team support: workroom snacks, drinks, frig, microwave Team meals: breakfast, lunch, dinner at least once/week during high enrollments (community donor list, internal funds)

7. Time and Effort Staff assignments according to licensure requirements Establish team leaders Identify staff talents: phlebotomy, tech savvy, phone communication, social planning, Quality management make it happen!! Continue to provide feedback Allow one day each week with no enrollments for catch up

8. Outcome of Research Studies: Where are we now? Successful recruitment and ongoing follow-up of Phase I and Phase III CoVID-19 vaccine trials Remote Regulatory ongoing and efficient Rapid enrollment accomplished: 250 in 4 weeks, using 4 clinic rooms, 4 days/week. Visits scheduled every 2 hours. Moderna study: 3 visits for each subject over 2 months. Janssen study: 2 visits over 1 month. No staff illness Effective use of POD OOW visits for prior studies per sponsor Work with other divisions to use ECC-RU