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Site Relationships:Why They Matter And How To Foster ThemKelly White, Project Manager, Stiris Research
PRESENTED BY: AND
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Slides and recording will be distributed to all registrants Use mic & speakers or call in Submit questions via GoToWebinar portal
Kelly WhiteProject Manager, Stiris Research Trauma and Critical Care nurse 18 years in clinical research
CRA Regional Clinical Operations Manager Project Manager
Expertise in Personalized Health Care Risk Based Monitoring
Agenda
Why Do Site Relationships Matter? Why Is It Difficult At Times? What Can We Do To Improve Our Relationships? Site Relationships 101 – Key Takeaways Q&A
Site Relationships: Why They Matter And How To Foster Them
Site Relationships
CRITICALLY ESSENTIAL
But often underestimated!
For our partners For our business For our sites For our patients
Why Do Site Relationships Matter?
Site Perspective: trust, comfort and reliability
Sponsor or Partner Perspective: a positive and consistent impression in the field
Clinical Research Organization: often the ‘pivot point’ whereby the Site and the Sponsor come together; ultimately to the patient benefit
The Bottom Line
We are all people…
Patients Sponsors Sites CROs
People tend to thrive and succeed under circumstances of trust and familiarity
Are We All Pulling It Off?
For the most part we do and we intend to, but...
Messaging from Partners: “Site Relationships are very important to us” “We want you to take this project on and help us rescue our site
relationships”
Leads us to believe there is room for improvement
Why Is This Difficult At Times?What Are The Various
Barriers?
We All Have A Gazillion Things To Do
…And Some Seriously Important, Non-Negotiable Responsibilities
In An Increasingly ‘Remote’ World
Relationships require a bit more thought and ingenuity than in the past “On Site” CRA visits are not as frequent and often extremely busy PM responsibilities greatly reduce opportunities for “On Site” time Key Global Roles have the least opportunity for local F2F interaction Investigator Meetings are more frequently remote meetings
Technology
Site relationships require “old fashioned” thinking
Industry Explosion
Science is moving at lightening speed Many new, talented members have joined the industry: PMs, Scientists, CRAs
In 2015 over 10,000 CRA positions open in the USA alone They know their regulations, GCPs, and core competencies, but…
Have we afforded the time to share, mentor, and demonstrate the art of the Site Relationship? Have we fostered the chance for everyone to gain experience and comfort with building the
Site Relationship? Have we overlooked these aspects?
What Can We Do?How Will It Help?
Solutions And Suggestions
Start with your own team base Do they know anything about each other? Regular calls to touch base
Remote team calls Offer pictorial introductions Share something about yourselves Use comical (but appropriate) examples within your training sessions
Kelly White 1991-2001: Trauma/ICU Nurse 1995-1999: Medical Advisor to
Local Film and Television Industry 2000-2004: Industry Contract CRA
Work 2004-2014: Roche Canada as a
CRA and Resourcing for Oncology in Canada
2014-2016: Regional Clinical Operations Manager for the CRA Group in Canada; Initial Team Build for the Quintiles-Roche Partnership Model
2016-Present: Project Manager at a Dog Friendly Company called Stiris
Involve Key Global Roles
Seize opportunities to have them interact with sites Give them a name and personal relationship Key Global Roles
Global Project Managers Science Team Data Management Biostatistics Medical Monitor Lab Manager
Lead By Example
Attend a site visit with your team members Partner a senior-level mentor with a more junior team member Extend beyond the CRA role
PMs and other team members need mentoring too! Assess before the visit: Are there areas where the team member has experienced
difficultly? Repeatedly turned down for PI meeting Site staff possibly being too busy
Review past situations and actions Assist to re-formulate a new approach
Remote Strategies to Foster your Site Relationship Pictorial introductions
Invite the site team to prepare and share if they are comfortable Ask site members to present topics as well!
Help your team learn to plan Work around clinic times for your calls Suggest that the site choose from 3 or 4 dates and times rather than suggesting only 1
opportunity Make mention of successes and celebrate them Plan ahead for deadlines; outline tasks and timelines simply and easily Always have a plan B
Teamwork
Ensure your sites know you are on the same team
What can we sort out together?
What are the Results?
Sites Tend to contact you more often Less chance of misunderstandings, mishandling of the protocol, or surprise issues Have confidence with the study and this translates into their interactions with their
patients
Patients Likely feel secure and fully informed when interacting with the site staff
What are the Results?
Sponsors and Partners Benefit from the great relationships that all team members have with a site Last minute changes or queries seem to run more smoothly
CRO Livelihood depends heavily on this relationship Afforded the opportunity to help bring treatments to patients
Key TakeawaysSite Relationships 101
Site Relationships 101
This involves all levels of the team and all should be treated as equally important
from the Global Science Leader to the person that books your visits and greets you at the clinic front desk!
Site Relationships 101
Key Takeaways Ones level of education, years of experience, or GCP exam score does not
translate to their level of comfort or ability to foster effective site relationships Please do not assume Lead by example in a non intimidating fashion Offer remote suggestions and strategies Build their confidence and be available
Site Relationships 101
Core Competencies, Scientific Knowledge, Safety Vigilance, Interpretation and Application of GCP and Regulations are responsibilities that cannot be diminished at anytime
Relationships that you build are the key to effectively driving these clinical trials Measuring Stick
The day that a prospective new partner does not feel the need to remind us that site relationships are important. It will instead be an unspoken given.
Thank YouKelly White
Project Manager, Stiris [email protected]
Q&A
Melanie CiottiMarketing Strategist, SDC