Written by: Elizabeth Adeusi, MHA, PMP

Presentation Overview

On November 14, 2024, the Clinical Research Forum of the PMI Atlanta Chapter hosted the Channel Your Inner Child To Become A Better Clinical Research Professional event as presented by The Q-Kids: John R. Nocero, PhD and Andrea L. Bordonaro, MAT.

Andrea and John emphasized that in the stressful world of clinical research, becoming overwhelmed by your emotions can happen to all of us. Emotions are your brain’s way of telling you something good or bad is happening in your life. To emotionally regulate yourself means you can step back from whatever emotion you are experiencing, identify it, and manage it as needed. As a result, an approach taught in schools worldwide for more than 15 years and bringing it into the clinical research world can result in better relationships with your colleagues. It’s emotional intelligence on steroids — The Zones of Regulation.

John explained the Zones of Regulation further. There are four zones: blue zone, green zone, yellow zone, and red zone. It is important to identify what zone you are in and manage it as needed, even in Clinical Research, as this can make all the difference in efficacy and results.

Takeaways

• Emotions do matter. They are incredibly important.
• The Zones of Regulation give us a concrete strategy to maintain emotions in various situations.
• Learning to recognize and regulate our emotions daily is beneficial in our personal and professional lives.
• When we can easily identify our zone as we navigate our day-to-day, we are able to recognize and utilize effective strategies to move us to a more comfortable, successful, and positive place. In turn, we can then make better decisions, improve our interpersonal relationships, and feel better about the aura we put forth about ourselves, which directly impacts how others view and interact with us.
• Use your next team meeting to introduce the Zones of Regulation to your research staff or as an employee engagement activity. This type of employee engagement—the connection that an employee has with their team, their job, the company culture, and the company itself—can have real impacts on productivity and well-being.

Next Event

Join us at the next PMI Atlanta Chapter Clinical Research Forum in March 2025.

Register at www.pmiatlanta.org/events/event-calendar

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Written by: Dr. Catherine Binuya 

Presentation Overview

Omer Bozok, PE, founder of Pheonix iO, has ten years of experience in geotechnical and civil engineering. His contributions to the field include working in electrical utilities, oil and gas, waste management, and mining. He is the lead author of “NextGen: Engineering: Excelling, Practice, Empowering People.

Drawing from the wisdom of Sun Tzu’s writing in the seminal classic literary text, The Art of War, Omer Bozok presents a framework for a strategic approach to implementing AI for industry success. By connecting principle to practice, Bozok, proposes strategy and a playbook for leveraging AI that speaks to safety, security, and responsible innovation.

To be victorious, one must strategically plan first, know the organization, understanding readiness and constraints, have clear goals, and sagely pivot plans in response to circumstances.

Takeaways

• Strategy: Laying Plans, The Five Factors that determine outcome
  • Moral and Ethics
    • Based on loyalty, shared purpose and value, and motivation
  • Heaven ~ External tactics
    • Recognizing cycles and market forces
  • Earth ~ Logistics
    • Based on data, technical infrastructure, budget, and AI team
  • Commander
    • Wisdom drawn from sincerity, courage, and strictness
    • Requires strategic vision, governance, and empowerment
  • Method and Discipline ~ Professionalism
    • Outline goals, procedures, metrics, continuous improvement, governance, and oversight

Each of the five factors has several key pillars.

• Playbook
  • Involves five steps: strategic planning and goal setting, assessing, identifying and prioritizing gaps, setting timelines and milestones, and implementation
  • Rank (1-5) for the average score of the pillars for each of the five key areas: Ethics, Market Forces, Logistics, Leadership, and Professionalism to assess an organization’s readiness and constraints
  • Prioritize importance and feasibility of strategic plan scenarios to determine plan for victory/success
    • 1-3 scale: Minimum, Moderate, Critical

Next Event

Register at www.pmiatlanta.org/events/event-calendar

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Written by: Kayla Burrell, MS, CSM

Presentation Overview

On September 12, 2024, the Clinical Research Forum of the PMI Atlanta Chapter hosted the “Strategies for Effective IRT Vendor Management in Clinical Trials” forum event by Gayle Flynn. Ms. Flynn spoke to the audience and shared some key knowledge about best practices for Interactive Response Technology (IRT) vendor management that can help sponsors and study teams achieve their objectives and ensure compliance with regulatory standards. Those best practices are through proper vendor management, project management, communication, risk management, compliance, training, and support.

Ms. Flynn explained that IRT is a system used in clinical trials to manage patient randomization, drug allocation, and inventory tracking. IRT increases efficiency, provides up-to-date patient enrollment information, and helps ensure regulatory requirements adherence. Ms. Flynn broke down the best practices for IRT vendor management as follows:

• Vendor Selection: The importance of the vendor's experience, technical capabilities, regulatory compliance, and support will determine the vendor’s capabilities and ability to tailor solutions to your specific needs.
• Project Management: It establishes clear project timelines and milestones and tracks the progress and performance of the vendor.
• Communication: Establishing and maintaining clear and consistent communication with the vendor and the study team to promptly address any issues or changes.
• Risk management: Properly identify and mitigate potential risks and challenges that may arise during the study and prepare contingency plans.
• Compliance: Ensure that the IRT system meets the industry standards and regulations, such as ICH E-6, ICH E-9, and 21 CFR Part 11, and undergoes rigorous testing and validation.
• Training and support: Provided to the study team and the site staff to help ensure user satisfaction and feedback.

Takeaways

• All it takes is one glitch to cause a quirky issue with IRT to bring an entire clinical study to a halt. That is why it is important to follow best practices and implement effective strategies.
• Additional strategies that have been proven effective in ensuring success with IRT are implementing monitoring and quality control, change management, and post-implementation review measures such as lessons learned and strengthening ongoing relationships.

Next Event

Join us at the next PMI Atlanta Chapter Clinical Research Forum on Thursday, November 14, 2024.

Keynote Presentation: TBD

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Written by: Nelly Eziashi, MBA, PMP

Since 1993, the Farmworker Family Health Program (FWFHP) has transformed farmworker health through collaborations with health clinics, public health districts, Georgia universities, and corporate partners like Philips. Now in its 31st year and housed at Emory University's School of Nursing since 2001, the program has served over 17,000 individuals. The speaker presented highlights of FWFHP’s journey, showcasing its partnerships and innovative healthcare services delivered directly in the fields, camps, and schools, making a lasting impact on farmworker families.

Presentation Overview 

The Farmworker Family Health Program (FWFHP) is an inter-professional collaboration that has addressed the healthcare needs of over 15,000 migrant farmworkers and their families since its inception in 1993. Based in Georgia, the program operates in collaboration with local clinics, farmers, and churches to provide healthcare services during the peak migrant season each summer. Students from university clinical programs also participate, gaining invaluable experience. Services include preventative and episodic care, sliding-scale medications, and health education, with electronic maintenance of patient records continuing year-round.

Originally started at Georgia State University’s School of Nursing, the program moved to Emory University’s Nell Hodgson Woodruff School of Nursing in 2001. Over its 29-year history, the FWFHP has become a key initiative in addressing critical healthcare needs while simultaneously enhancing student education through hands-on training. Each year, it serves over 600 individuals, making a significant impact on Georgia’s migrant farmworker communities.

Takeaways

Effective project management has enabled the FWFHP to improve patient outcomes, make data-driven decisions, and sustain and scale the program for over 31 years.

• FWFHP Life Cycle Summary:
  • Initiation [Jan/Feb]: Define scope and establish Memorandums of Understanding (MOUs).
  • Planning [Jan – June]: Meet with stakeholders, gather supplies, and build the schedule.
  • Execution [June]: Set up, deliver services, and collect data.
  • Monitoring & Controlling: Manage the schedule, monitor weather, and hold daily retrospectives.
    Closing: Complete evaluations, debrief, and generate reports.

• The project management knowledge areas for this program can be summarized as follows:
  • Integration: Managed through resource allocation and status meetings to keep everything aligned.
  • Scope: Driven by the program’s mission statement, ensuring all activities align with core objectives.
  • Time: Timelines are dictated by partnerships, particularly with farmers and community stakeholders.
  • Cost: Costs are shared across stakeholders but present challenges due to funding limitations.
  • Quality: Ensured through continuous quality improvement (QI) initiatives.
  • Human Resources: Focused on team advocacy to support both staff and participants.
  • Communications: Leveraged tools like GroupMe, whiteboards, team meetings, and Google Drive for collaboration.
  • Risk Management: Includes standard operating procedures (SOPs), COVID-19 evaluations, safety huddles, and hotel rooming arrangements.
    Procurement: Involves working with community and corporate partners, along with donors, to acquire necessary resources.
  • Stakeholder Management: Collaborates with school districts and local farms to ensure stakeholder needs are met.

Next Event

Join us at the next PMI Atlanta 3rd Annual Special Interest Forums Joint Open House! “Project Management and Beyond 2.0 – A Peek Into The Future” on Tuesday, October 15, 2024

Panel Discussion Topics: Skills Development, Resume Review, the Impact of AI, and DEIAB (Diversity, Equity, Inclusion, Accessibility, and Belonging)

Register at www.pmiatlanta.org/events/event-calendar 

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Written by: Mike Ososki, PMP

Presentation Overview 

At the forefront of business transformation and growth for the State of Georgia, we have the Georgia Center of Innovation, where Asante Bradford is a major player. His extensive background in Creative Media brings technical industry expertise to foster research collaborations and form strategic business partnerships, enabling the entertainment industries in Georgia to connect, compete, and thrive. Asante also educates prospects about the Georgia Entertainment Industry Incentives Act to support, promote and grow our industry here.

Takeaways

Our Georgia entertainment industry is alive and well! may be Asante’s primary message. Between media, film, TV, radio, theater, music, sports, fine arts, and especially the monetary
juggernaut of digital gaming, we have all of it well-covered.

• Film production: Georgia is #1 among all US states
• Video gaming is now a $200B+ industry worldwide—larger than film, TV and music combined, and we have our fair share of talent making this happen.
• The Creative Economy will only grow. Earlier in his career, Asante fought to advance acceptance of YouTube and streaming. Now it’s VR, AR, AI, 6G, Web3, and blockchain. He’s striving to achieve more K-12 education and seed investment to fund projects, so we can continue staying ahead of the curve.
• Education is needed to help creative professionals know how to pitch better. “Anything you can create to make money.”
• All entertainment-related industries continue to converge and integrate more.
• Pair up gifted, motivated students with savvy corporations to create social media and intellectual property that create generational wealth.
• Hot career paths that quickly pay well: “prompt engineering” for AI, and Unreal Engine for 3D graphics.
• We can’t live in fear. You must push boundaries to welcome and embrace new tech, or you’re gone. AI will never replace human creativity, which nothing

Next Event

Join us at the next PMI Atlanta Entertainment Forum on Thursday, November 21, 2024

Register at www.pmiatlanta.org/events/event-calendar