Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career.
You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals.
Clinical Trial Readiness with Joel Selzer
One of the biggest challenges in clinical study start-up and conduct is “training.”
A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more.
With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary.
In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx.
Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training.
We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more.
I hope you enjoy my conversation with Joel Selzer on Clinical Trial Readiness.
Clinical Research Soft Skills with Ed Hogan
Many people tout about technical skills in clinical research.
You need to know Microsoft Excel.
You need to understand Good Clinical Practice.
You need to memorize the FDA guidance documents.
Have you ever heard someone talk about soft skills in clinical research?
I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager.
When you work with a diverse team, you must master soft skills.
Soft skills, also known as “real skills”, help you learn, adapt and grow.
In this interview, I invited Ed Hogan, Executive Vice President (EVP) at Invicro, to talk about soft skills in clinical research.
Ed and I first met in 2005. He was the Director for Medical Imaging at PAREXEL/ Perceptive Informatics, my first job out of college.
Ed is now responsible for overseeing the clinical services team which includes project management, imaging services, data management and reader management for early and late phase clinical trials.
Ed has close to three decades of experience in clinical research, managing, and executing Phase I through Phase IV imaging trials in both the Pharmaceutical and CRO space.
He is THE expert when it comes to medical imaging operations.
Ed has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements.
For these reasons, I invited Ed to talk to us about soft skills including negotiating contracts, how to develop a successful manager-employee relationship, what Ed looks for when he is wanting to promote someone on his team, leading effective meetings and much more.
I hope you enjoy my conversation with Ed to the Clinical Trial Podcast
[3:50] Soft skills and project management
[4:54] Negotiating contracts with Sponsor including cost, study design, and operations
[7:25] Offer Sponsors what they need and not nice-to-have elements
[8:24] Clinical project managers are involved in finances
[10:22] Ideally Sponsor should ideally have a direct communication with imaging CRO
[11:59] Example of risk mitigation in clinical trials
[13:39] Developing soft skills through PMP certification and courses and on the job training
[14:45] Managing and working with project team members
[17:21] Developing a strong team with diverse and complementary skills
[19:01] Putting in time and practice to develop your skills
[21:01] Soft skills are not easy to do
[22:28] Key ingredients that make a successful manager-employee relationship
[23:52] Giving direct and timely feedback
[25:37] Feedback “sandwich”
[26:32] Managers can plan and prepare before giving feedback. (a) State the outcome, (b) state the issue, (c) listen, (d) reinforce your intent to help, (e) repeat the end goal and expected outcome, (f) followup with an email
[28:51] Practical advice on managing up
[31:54] Giving and getting feedback from your colleagues
[34:06] Developing writing skills
[36:01] Understand pain points to create winning proposals
[37:23] Finance skills such as dealing with budgets, ability to write and communicate effectively, multitasking, time management, learning styles are some of the skills Ed focuses on when promoting or hiring someone new
[40:41] Getting your foot in the door with entry level clinical research roles
[45:54] Dealing with emotional employees when giving feedback
Never Split the Difference with Chris Voss
Project Management Professional (PMP) curriculum
Radical Candor by Kim Scott
StrengthsFinder 2.0 by Gallup (Author)
The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni
Myers Briggs Personality Test
Official Microsoft Excel Video Training
The 7 Habits of Highly Effective People by Stephen R. Covey
Patient Support Programs in Middle East and North Africa (MENA) with Maha Dakhloul
In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region).
Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials and PSPs in the MENA region and much more.
This interview was recorded shortly after the explosion in Beirut in August 2020. I’d like to thank Maha for taking the time to chat even though her city was experiencing such pain.
Maha has a bachelor’s degree from the Arab University of Beirut. She has worked as Clinical Research Coordinator, Clinical Research Associate, Regulatory Affairs Manager, Clinical Project Manager and is currently the Clinical Operations Manager at Phoenix Clinical Research .
Please join me in welcoming Maha on the Clinical Trial Podcast. Maha Dakhloul on LinkedIn
Career Development in Clinical Research with Chris Lewis
Starting a career in clinical research with little or no experience can be difficult.
Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization.
In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research.
We talked about the future of the CRA role and what skills are needed to succeed in today’s marketplace.
Chris has over 20 years’ experience leading teams and managing clinical trials in the medical device, biotech, and pharma industry.
At IntersectENT, he serves as Vice President, Clinical and is responsible for developing and managing clinical programs.
Chris graduated from the University of Louisiana, where he received his Bachelor's degree in Biology and an M.S. degree from George Washington University.
During his spare time, Chris enjoys vacationing in our national parks with his family, trail running, camping, and pretty much every other outdoor activity under the sun.
Please join me in welcoming Chris Lewis on the Clinical Trial Podcast.
Chris Lewis on LinkedIn
Trainual software for onboarding and SOP training
How to Win Friends and Influence People by Dale Carnegie
Good to Great: Why Some Companies Make the Leap and Others Don't by Jim Collins
1:52 Chris unconventional path to clinical research career 2:38 Journey from research coordinator to vice president 3:18 Impact of rise in technology, remote monitoring and risk based monitoring on the CRA’s role 5:49 Who is responsible for proctoring clinical trial cases? CRA or Field Clinical Engineer (FCE) 6:49 Importance of relationship management, technical expertise, problem solving skills and staying calm in the operating room 8:05 Building interpersonal skills through partnership and collaboration 9:34 Consolidation of electronic systems and access to sites 12:25 Process of hiring, interviewing and finding right talent 14:31 Leveraging social media (LinkedIn) and internal human resources systems for hiring 16:12 Getting to know someone through their hobbies, mannerisms, eager to learn, work hard, and ability to getting along with the rest of the team 18:03 The importance and process for having difficult conversations 22:53 Getting the new job posted Creating clear job description Making a request for requisition Getting it approved through HR and executive 23:29 Making an offer Confirm with HR is the requisition is still valid Obtain executive approval stage Clean communication between the candidate and hiring manager throughout the process 25:58 Onboarding new employees needs to be planned Create an onboarding plan Clearly articulate and set expectations Training Plan Assign a mentor/ buddy (not their manager) Weekly meetings Access to systems 28:34 Providing ongoing leadership and management 32:33 Core skills i.e. soft skills needed for a clinical research professionals How to get along with people and see their viewpoints How to manage a challenging situation 36:30 You don’t need two years of experience to get a job in clinical research 38:03 Getting into clinical research career with no experience Getting a masters degree in clinical research Making contacts and exploring LinkedIn 39:19 How does living on the farm impact Chris’s life at work ? 41:00 Take control of your career, have patience, get your manager to understand your career aspirations Resources Mentioned
Abbott Trianual - software solution for onboarding and SOPs [Book] The 7 Habits of Highly Effective People by Stephen Covey [Book] Good to Great by Jim Collins The Clinical Research Administration Program at George Washington University
Solving Patient Recruitment Challenges with Maya Zlatanova
I’m always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion.
Our guest on today’s show is Maya Zlatanova, CEO of FindMeCure.
Maya and her team are creating a “google” for clinical trials.
She is on a mission to make it easy for patients to find ongoing clinical trials She wants to solve patient recruitment challenges enabling patients and doctors to connect with each other She believes in the power of stories, not just facts, something unheard of (but much needed) in clinical research. FindMeCure is dedicated to simplifying the patients' journey while volunteering for a clinical trial while helping the industry plan their trials with the full picture of country capacity, sites' experience and patients needs and journey.
Maya is a healthtech entrepreneur, clinical research expert, and pharma industry speaker with over 15 years of global experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations.
Maya’s strongest skill is empathy.
Her principles in life are to be trustworthy, care for other people and give first.
She also cherishes her never-ending curiosity about how life and the universe work, how to improve ourselves and our environment.
Please join me in welcoming Maya Zlatanova on the Clinical Trial Podcast.
[2:25] About Maya’s company FindMeCure, Maya’s experience working on clinical research software for the British government and first online GCP training
[4:14] Maya’s sister was diagnosed with an eating disorder and struggled to find treatment. This let to Maya looking at clinical trials from a patient perspective
[6:06] Creating a global platform for patients to find out about alternative treatments in clinical trial setting
[8:29] Connecting patients in one country with clinical trials in another country
[9:55] Challenges for patients include:
Human factors such as need to be close to family Traveling long distances to participate in clinical trials Being treated by different doctor (trial investigator) than their primary physician [13:01] Patient recruitment process can benefit from change. Currently we first select sites and then bring patients into these sites
[14:26] We need to break things to innovate
[15:25] In an ideal world, we would have a centralized electronic health record, we know where patients are, patients are monitored with telehealth solutions, central site that is leading other sites
[16:55] Everyone wants to go to the experienced sites
[19:43] Hybrid clinical trials
[20:28] Need to support sites and investigators by questioning what sites should and shouldn’t do
[24:05] convincing decision makers to select sites in other geographies using financial metrics
[28:03] Language is not an obstacle at most sites. Ethical considerations can pose an issue.
CRO with local office Site Management Organization (SMO) Own CRA networks [32:00] Adoption of technology in clinical research such as sites being open to new remote solutions
[33:35] Whatever works for clinical research will work for the healthcare sector
[34:03] ACRES helping sites getting accredited and certified if they follow certain standards for clinical trials
[36:32] GCP is the only standard in clinical research. For example, it is not sufficient for patient centric trials
[38:02] Need to align on initiatives such as patient engagement guidelines in EU and USA
[39:45] Empathy is a feeling for people and imagining yourself in their shoes. Being open to the fact that you could be wrong. Listening to people, hearing you are wrong, and converting to the right thing
[42:42] Maya’s secret weapon is speaking with different people with different backgrounds to learn and grow
Society of Clinical Research Sites (SCRS)
Association of Clinical Rese
Patient Centricity in Clinical Trials with Craig Lipset
Customer ReviewsSee All
A wonderful podcast that flows really well! Kunal asks some great questions that listeners want to know. A nice variety of topics and very enjoyable overall! Even to someone new in the clinical trial world!
Very professional and well formatted
This show is packed with efficient and relevant info. No wasting of anyone’s time.
As a pharmacist looking to get into the clinical research industry, I have found The Clinical Trial Podcast indispensable. Kunal's articles about gaining experience are especially helpful. I have put his advice into action, and am making progress! If you are looking to get into or improve yourself in this industry, listen to this podcast!!