31May

Welcome back to #WeAreGreenKey, where we shine a spotlight on our powerhouse recruiting team.  

We recently caught up with Jon Danko, Executive Director on the Healthcare team at Green Key. Jon started his recruiting journey after gaining experience working in sales. Since joining Green Key, he has transitioned to travel nursing recruiting and is looking forward to streamlining that area even more.

Can you share your career journey and how you progressed to your current role? 

Sure, so after I graduated, I started working in sales and worked my way up to management where I became the area manager at a car rental company. I then I took a leap of faith and started recruiting with no experience at an agency where I worked my way into a sales role there after that, I switched over to travel nursing. After working in this role, a colleague of mine and I came to Green Key and started the division a few years ago. He has now moved on, and I have taken on the division along with Victoria Ceballos.  

What have been some of the most rewarding aspects of your career? 

My job is rewarding. I love staffing to be honest. It’s such a good feeling when you make a placement and they’re so thankful. Life is tough and you were able to help change their situation or even just give them advice. That means a lot to me. I also enjoy seeing my colleagues grow and succeed. For instance, Victoria and I took a leap of faith and switched over to travel nursing. To see our ideas blossoming is so rewarding. 

How do you balance the use of AI technologies with traditional recruitment methods in healthcare, ensuring a human-centric approach while leveraging the benefits of automation and data-driven insights? 

In my role, I love using AI to help increase the professionalism in my writing. However, I see a lot of people have been using AI as a writing tool, so I have dialed it back a little because I want to still have that human touch as well. I also love using AI to help me create eye-catching titles or subjects for my emails. Overall, AI has been a great in my toolbox.  

What advice would you give to candidates looking to stand out in the healthcare job market? 

Oh, be sure to tailor your resume for every job. You cannot have the same resume for every job that you apply to because a lot of these companies use AI to review resumes and it looks for certain buzzwords in a resume. You also need to be very direct and clear about all your experience as job titles can differ for the same role.  

How do you stay updated on changes and developments within the pharmaceutical industry to better serve your clients and candidates? 

I use LinkedIn a lot and read different articles. I also stay connected with many of my clients, who always have a lot of insight into conferences and can inform us of what is coming. I am also in a lot of healthcare groups on LinkedIn and Facebook.  

Do you have any new professional goals, either for yourself or your team?   

Yes, we are aiming to continue to grow the division and hire more passionate team members. 

Jun 6, 2023

How to Write a Clinical Study Report

If you’re new to clinical research, or even if you’re not, sooner or later you’ll be tasked with authoring a clinical study report.

These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.

“A clinical study report (or CSR for short),” explains Eli Lilly in a blog post, “Describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective.”

The first questions a novice report writer may have, therefore, are “What do I include in the report,” “What’s the report structure,” “How do I write the report”?

The International Conference On Harmonisation answers those questions in a 49 page guideline that spells out the details and includes sample forms.

Even with the guidelines, preparing a study report is complicated work, requiring the collection of data, analysis and making sure it is both accurate and complete.

Fortunately, the Association of Clinical Research Professionals recently published a much less intimidating primer answering those questions and many more. “Clinical Study Reports 101: Tips and Tricks for the Novice” provides an overview of the CSR, giving us a framework for writing and organizing a report.

The author, Sheryl Stewart, goes into just enough background to give a first time author or contributor an understanding of what needs to be in these reports and why. That goes a long way to helping us know what a report must include. She helpfully points to templates, and reassures us that “there are no requirements to follow the template precisely. Not every section is appropriate for every study.”

Her top level discussion tells us the first step is to review the templates she recommends to help you organize the report. Outlining it will tell you what documents and data you’ll need.

The next step is to identify all the stakeholders. These will certainly include the clinical study management team, those tasked with responsibility for the data and others. In a “Tips and Tricks” section Stewart suggests, “Drafting a project charter or scope document to ensure commitment from all required teammates on scope, deliverables, and timelines.”

Each of the stakeholders should be given a time table for their deliverables. “Time management is paramount for clinical trial submissions to regulatory authorities,” Stewart says.

In her section on the writing of the CSR, Stewart briefly discusses each of the six sections, offering insights into the process. Write the executive summary last, she suggests, because it will be easier then.

She also has a few tips about the review process. Have the reviewers initially focus on content. Formatting and grammar errors are much less important at this stage. She also says that once the review team has signed off on a section, discourage backtracking unless something major changes.

How long should you expect the process to take? Experienced writers surveyed at medical writing conferences came up with an average of 17 days from delivery of the final tables, listings, and figures to first draft. And 26 days from first draft to the final draft sent out for review.

Photo by Scott Graham on Unsplash

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