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HD InsightsFeatured Story: Coaching the Point Guards

Coaching the Point Guards

HD Insights interviewed Jody Goldstein, who reflects on being a “coordinator of coordinators.” Yes, it’s complicated, but the rewards are rich.

Jody is the Director of Clinical Operations for HSG, she is the Chair of the HSG Member Education Committee, Co-Chair of the HSG Executive Coordinator Council, and a member of the HSG Research Advisory Board. Her expertise in study start-up (protocol and consent development), innovative patient recruitment, and clinical trial site education has led to the successful initiation and implementation of over 15 HSG clinical trials. She has served as a member of the HSG Executive Committee, Project Aware Committee, and HD Communications Committee. Due to her commitment to educate and support coordinators, Jody was recognized with the 2015 HSG Coordinator Mentorship award.


A Rapid-fire Onboarding

MCAT scores in hand, Jody Goldstein was set to pursue a career as a physician, when the love of an HD clinical research coordinator job interfered. Twenty years later, she is helping scores of new or rising clinical coordinators realize some of the success, contribution and gratification she has known.

Jody’s career path in clinical research began when she met Dr. Jody Corey-Bloom, Director of the University of California at San Diego (UCSD) Huntington’s Disease Clinical Research Program, in 2001, and was introduced to the Huntington disease community. She recalls her first days as a clinical research coordinator at UCSD: “The HD team members heaved a sigh of relief when I arrived, and gave me a stack of charts as big as I was to review,” she said. “I remember their saying, ‘Let us know if you have any questions,’ as they walked out the door.”

Well, she had quite a few. While she had experience in patient care and a business background, Jody didn’t know much about HD. Thankfully she had a very supportive team who welcomed her questions. To this day, Jody tells coordinators, “Don’t ever be afraid to ask questions — it is one of the most important things you can do to learn and become effective.”

Jody immersed herself in HD by reading books, scouring charts, reviewing patient videos, and learning about HD symptoms and medications prescribed. She immediately forged strong bonds with families impacted by HD and began to develop top-notch skills as a clinical research coordinator.

During her time at UCSD, Jody participated in other activities, including genetic counseling and testing, running HD support groups, and educating the community about HD. In addition, due to her bicultural background (her mother is Mexican), she was able to engage the HD Hispanic community to come to the clinic and participate in research.

Coordinating Coordinators

In 2012, Jody was presented with an opportunity to use her experience as a clinical research coordinator to enter a project management role, running global clinical trials with another of her mentors, Elise Kayson, M.S., ANP, at the University of Rochester in Rochester, New York. “It wasn’t an easy decision to leave my UCSD team and San Diego HD families,” she said. “They were family to me.”

It was her colleagues and HD families who ultimately encouraged her to accept the job. “They knew I could make a larger footprint in the HD world through this new position. I took the job on the condition that I could be a project manager who would be there for all of the sites, so that they could concentrate on their research participants and studies. I wanted to teach, coach, and help sites to become successful at running clinical trials and bringing study results faster to the HD community.”


An Audit-ready Preparation

Preparation for a clinical trial starts well before the site is selected for a study. Having been been part of a successful FDA site audit for the tetrabenazine study, helped prepare Jody to teach coordinators the importance of being audit-ready. Part of the coordinator’s responsibility is to work with the investigator to learn about the study design, understand the requirements of the protocol and determine if the site has enough appropriate patients who meet the eligibility criteria.

“Your job is to learn every aspect of the study – what it requires, what staff you need (pharmacy, laboratory, imaging, etc.), the budget side of things, and the regulatory side of things (IRB),” she said.

In addition to navigating conversations with potential and established trial participants, another role of the clinical research coordinator is to ensure protocol compliance. “You have to be obsessive about documentation. If you don’t document that you ask all the required questions every time, it’s like it never happened.” This balancing act is one of the arts Jody teaches. “I remind coordinators that it takes time to train yourself to do this gracefully.”

Rapport Matters

Once these questions are answered, Jody says the success of each trial depends largely on the relationships you create. “One of the things that I learned very early on is that you need to build a rapport with everyone”. This includes not only patients and families but also other health care professionals.

A clinical coordinator depends on myriad people who work outside the clinic to get the trial done. Working to be “top of the list” for those who control trial resources means first earning their respect. “You are in a situation where there are competing contracts. My mentor, Dr. Corey-Bloom, and I made sure our applications were straightforward and without gaps. That way, the finance team or the IRB analysts, for example, would see our names on the application and feel comfortable committing resources to our project because they knew we were well-prepared.”

Not only did this benefit Jody’s team, but it made the other groups’ jobs easier. “Time is saved on their side when you fill in all of the gaps in advance, provide the teams with all necessary information to complete their side of the project, and provide clean and accurate information,” she explained.

The Trial Participant at the Center of it All

After the preparation, the most important part – recruitment – begins.
“You have already worn your scientist hat, learning about the drug and knowing the protocol backward and forward so you can answer any question participants might have,” Jody said.

Then, a different hat becomes primary. “Recruiting starts with empathy,” she said. “You really have to put yourself in the shoes of the person, whether they are at-risk, pre-manifest, prodromal, or manifest. They are the ones who are courageously willing to try a drug that is not approved by the FDA. They may be nervous or scared. You have to understand that they are participating not only for themselves but to benefit the next generation.” Jody says that successful clinical research coordinators learn to present the study in a positive, truthful light and provide as thorough an explanation as the patient can understand.

Coordinating Coordinators Worldwide

Today, Jody is the Director of Clinical Operations for the Huntington Study Group, and has shared her experience and wisdom with over 200 HSG site coordinators, traveling to work with new coordinators and help establish what Ira Shoulson, M.D., coined “tiger teams.” Tiger teams are well-prepared clinical research sites that are ready to take on a clinical trial at a moment’s notice. When sponsors ask the HSG to conduct a clinial trial, Jody has confidence that the tiger teams are ready to roll.

Jody’s commitment to research and her passion for the HD community are stronger than ever. Her goals for the future include continuing to mentor new and rising coordinators so they can realize the importance of their contribution and the gratification of knowing successful clinical trials will eventually lead to new treatments for the HD community.

“I love the fact that I have been a part of helping to support, mentor, and encourage people to become prepared for future endeavors and build career coordinators,”she said.

If you would like to contact Jody Goldstein she can be reached at: Jody.Goldstein@hsglimited.org or 1-760-845-2105.

Secrets of a Point Guard

Jody says her love of basketball and her experience as a point guard contributed to her ability to handle multifaceted projects, anticipating and managing what may lie ahead. “As a point guard, you have to know where someone’s going to be before the ball is passed — you have to know what’s going on before it happens. It is very similar in the clinic. You have to be aware of everything,” she said.

“You have to know what will make somebody want to participate in a clinical trial but you also have to know when it’s not the right choice. You have to know when somebody is anxious about a research visit and how to put them at ease. You have to know how to position your team to run an effective research visit.”

Jody says the beauty of the clinical research coordinator role lies in this point guard role and the breadth of the position. “You have the opportunity to be a scientist, logistical leader, educator and a counselor,” she said.

Jody’s Top 10 Recommendations to Become an Effective and Happy Clinical Coordinator

  1. Immerse in HD science, regulations and research
  2. Become an expert in each study before it starts
  3. Develop good relationships with everyone you work with
  4. Find a great mentor
  5. Learn to wear all your hats well
  6. Relish your point guard role
  7. Love and respect each participant
  8. End each research visit by saying thank you
  9. Know what you do is important
  10. Know that finding a treatment for HD is possible because of your dedication