Monthly Archives : November 2017

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STAFF SPOTLIGHT – PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

STAFF SPOTLIGHT 

PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

Four years ago, a voice from Patti Lawrence’s past called her cellphone. Jim Hart, Chief Executive Officer of Hart Clinical Consultants, needed someone with clinical experience working in a cardiac cath lab. From that one phone call, Patti began a new phase in her professional career as a Clinical Research Associate, initially filling device proctoring roles, but diligently training as a clinical monitor. For the difference between the two roles, click here.

Since those days in 2013, Patti has worked on nine medical device trials with HCC, as both proctor and monitor. When she first joined HCC, she had very little monitoring experience, so she read everything she could about it while she was mentored by Jim and Stan Reaves, HCC’s Chief Operating Officer. Certification as a Clinical Research Professional (CRP) requires a minimum of two years’ experience in the field. In October of this year, Patti took and passed the SOCRA CRP certification exam.

Please help us congratulate Patti on her earning the CCRP certification and on her recent promotion to Senior Clinical Research Associate. 

Patti’s continued commitment and contributions to HCC, shine through her with her obvious love for her work. According to Stan Reaves, among her many accolades is a vast knowledge of cardiac and vascular anatomy and physiology. This knowledge and many years in the cath lab translates to client appreciation for her ability to teach difficult topics with simplicity, great analogies, and examples that lead to a thorough understanding by the learner. Stan provided this story that exemplifies Patti’s contribution to HCC, “Patti saw a need for education of team members for a stroke intervention trial and put together a presentation to teach the folks working on the project. She has also recently taken on the lead role for a seminal peripheral vascular device study, for which she has developed a strategy for training 40 study sites as part of her responsibility for coordinating site coverage.” A can-do attitude, perseverance, and an aptitude for adapting to most personality profiles enables Patti to develop strong working relationships with even the most demanding individuals for the long game.

Medical Device Executive Eric Knuteson had this to say about working with Patti to support clinical trials at Osprey Medical (Minnetonka, MN), “She exemplifies professionalism beyond reproach and is a calm pro who is able to navigate any customer situation with intuitive approaches to details and challenging requirements. She sacrifices her personal schedule to meet any clinical last-minute need, like booking last-minute travel on a Sunday afternoon.”

Patti says she could not be happier than she is right now working for HCC. “I truly enjoy working with and meeting new people” she says of the job, and enjoys the travel associated with it.  She is planning to use some of the travel perks she’s been collecting to go experience the Aurora Borealis up close by standing underneath, listening to the hissing and crackling of this natural phenomenon.

We are blessed to have Patti as part of our HCC family. Thank you, Patti, for being a key player and for your continued commitment to excellence in all you do!

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

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Experience managing all phases of clinical trials

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Extensive on-site monitoring experience using a variety of data collection processes

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Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

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HART HEALTHY TIPS: THE GREAT AMERICAN SMOKEOUT

HART HEALTHY TIPS:

THE GREAT AMERICAN SMOKEOUT

Save the date Thursday, November 16th! The American Cancer Society holds a very important event that day, which can be the first day towards quitting smoking for many people.

It’s The Great American Smokeout!

According to the Centers for Disease Control and Prevention, approximately 36.5 million Americans (15.1% of all adults) smoke cigarettes. Smoking causes several life-threatening diseases such as cancer, stroke, lung and heart diseases, diabetes, emphysema, and chronic bronchitis. Over 16 million Americans have diseases caused by smoking. In the United States alone, cigarette smoking causes more than 480,000 deaths per year. The financial costs of smoking are significant with a $300 billion price tag in the United States, and direct medical costs of over $170 billion. Despite these costs, quitting can be difficult.

Many smokers want to quit, but don’t know where to start. According to a government study nearly 70% of adult smokers want to quit, but only 6 % could stop smoking. Withdrawal symptoms such as irritability, anxiety, having trouble focusing, feeling angry, cravings for tobacco products, and weight gain can make it hard to stick to a plan.  If a smoker can make it through these symptoms, the health implications are significant.

                                                                                                   *2015 Centers For Disease Control and Prevention

Health benefits begin within 20 minutes of quitting by lowering heart rate and blood pressure. After 1 year the risk of coronary heart disease is cut in half and after 5 years the risk of stroke is reduced to that of a nonsmoker. The risk of coronary heart disease returns to that of a nonsmoker 15 years after quitting. The sooner a person quits the better, too. Quitting at age 30 can add approximately 10 years of life expectancy compared to waiting until age 60 to quit, which only adds 3 years. A good plan can help reach goals of quitting.

The Great American Smokeout event is dedicated to increasing awareness of the importance of quitting and urges smokers to not only to quit for the day, but to make a plan to quit for good.  

Steps to a good plan for quitting:

  • Make the decision to quit
  • Pick a quit date and mark it on the calendar
  • Inform friends and family for support
  • Purge all cigarettes
  • Practice saying, “No thank you, I don’t smoke.”
  • Review support options such as nicotine replacement therapy, prescription drugs, support programs, acupuncture, herbal supplements, and mind-body practices

On your quit day, be sure to not smoke at all. Staying busy will help keep urges away. Be sure to drink plenty of water, start any nicotine replacement therapy chosen, and avoid situations where smoking is prevalent. If the urge to smoke arises, use the 4 D’s to help fight the urge: delay, deep breathe, drink water, and do something else.

So, take the challenge to invite a smoker in your life to the save the date, Thursday, November 16th, the first day to life without smoking.           

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

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Experience managing all phases of clinical trials

banner3

Extensive on-site monitoring experience using a variety of data collection processes

shutterstock_73949041

Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

conference

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

On September 28, 2017, HCC staff members Cheryl Calhoun and Stan Reaves attended the Vermont Cardiac Network (VCN) Conference held in picturesque Woodstock, Vermont. VCN was established in 1984 to assure cardiac health status of Vermonters and other nearby residents. It is a group of physicians and nurses committed to providing quality educational programs in cardiac care and networking for the healthcare communities within Vermont and western New Hampshire.  More information can be found about the organization here.  VCN holds three conferences each year and this year approximately 100 people attended this Fall conference.

Stan Reaves presented “Late-Breaking Cardiac Clinical Trials Update” to the group. Stan presented introductory materials on the evolution of clinical trials, emphasizing the key elements of patient safety, informed consent, and ethics.  By illustrating mistakes made in the past, he drove home the message of safety and ethics; capitalizing on the importance of patient advocacy in all that we do.  Stan also reviewed recent drug and device clinical trials relative to cardiac care with the premise of using clinical trials to “build a better pump, better pipes, or better valves”.

Stan’s presentation was well-received by the group, garnering positive comments on the evaluation form, such as:

As a result of this presentation, …

  • I will look into nursing research as a career; better understanding of symptom control, and when to make referrals.
  • I will be more careful to spend extra time with patients describing procedures to ensure they make informed decisions, i.e., consents. 
  • I will better walk patients through explanation of the informed consent process.

Other presentations included:

“Sleep Disorders and the Impact on the Heart” by David Alsobrook, MD (North Country Hospital, Newport VT), which addressed the normal sleep cycle, where in the cycle certain sleep disorders interfere, and the structural changes that occur in the heart and circulatory system as a result of prolonged periods of increased intrathoracic pressures and hypoxia.

“The Structural Heart Journey-Learning to walk, to running the Marathon” by Faye Straight RN, BSN CRCC (University of Vermont Medical Center, Burlington VT), which presented the evolution of the Structural Heart Program at UVMC, from their start with the Medtronic CoreValve Evolut R trial for high risk (high STS scores) aortic stenosis subjects to their current program on target to treat 200 patients with severe aortic stenosis by Transcatheter Aortic Valve replacement (TAVR) this year.

Hats off to VCN for their fabulous work for the people of Vermont and New Hampshire!  Check them out here.

Many thanks to Chery, who has served on VCN’s Board of Directors since 2012, and who provided excellent feedback on the conference for this post, and to Stan Reaves who gave an engaging and informative talk at this year’s Fall VCN Conference.

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

banner1

Experience managing all phases of clinical trials

banner3

Extensive on-site monitoring experience using a variety of data collection processes

shutterstock_73949041

Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

banner4

Cath lab professionals with extensive proctoring experience…HCC works with you