Category : HCC Press / News

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The Benefits of Being a Contracted Clinical Research Associate

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If you’re reading this, you’re likely not new to this industry.  But, just in case, a CRA’s primary job responsibility is to monitor clinical trials, ensure the protocol is followed and that all data collected is protected and verified. Depending on level of experience and protocol requirements, CRAs may also handle case-proctoring and device training.  The latter is often the case of CRA’s that work with Hart Clinical Consultants.

Winning the Hart Healthy Challenge One step at a time

If you’ve been following our recent blog entries, you know the background and premise behind the Hart Healthy Challenge during the month of February. In short, we believe a company’s internal culture can have a discernable effect on those that work within it. By design, HCC levels great value on how physical well-being can influence work-place and staff “barometers.” Using this philosophy as a motivator, our leadership team distributed Jawbone Up24 fitness tracking devices to all clinical research associates (CRA). Thus began a friendly competition to achieve the most steps, noting milestones and earning simple (but attractive!) prizes along the way. At the end of the month, first and second place winners received a predetermined amount of funding to donate to a local charity of their choosing.

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HCC Employee Donates $500 to Morning Dove Therapeutic Riding Inc.  

Noblesville, IN (March 16, 2016) – Janice Boyd, clinical research associate (CRA) for Hart Clinical Consultants (HCC) – a national clinical research organization (CRO) – donated $500 to Morning Dove Therapeutic Riding Inc. this week as a result of winning HCC’s “Hart Healthy Challenge,” a National Hearth Month initiative to support healthy lifestyles and give back to the local community. Using Jawbone UP24 devices to track their steps, the team members attempted to reach and surpass daily step goals. First and second place finishers were awarded cash prizes to donate to their favorite local charity.

“I chose Morning Dove for a number of reasons. As a nurse, I’m a caregiver by nature, but also a passionate animal lover,” said Janice, who owns two horses herself. “Morning Dove does an amazing job of helping people, primarily children, to work with physical and emotional challenges.”

The challenge not only gave Janice the opportunity to give back to her local community, but she also found an increased motivation to exercise. She became aware of sitting for too long and got creative with her efforts to achieve her daily step goal with activities like walking the dog, jogging in place, doing jumping jacks and sometimes just running around the house.

“I’m active by nature,” Janice said. “But the Hart Healthy Challenge drove me to move more than usual.”

HCC takes a personal interest in their staff and was thrilled when the team achieved a total of 3.4 million steps together. According to a study released in June 2015 by the Society for Human Resource Management, 70 percent of U.S. employers now offer some kind of employee wellness program. The trend of walking-based challenges like the “Hart Healthy Challenge” will continue to be popular in 2016, and HCC plans to organize another competition later this year.

“Everyone won something this past month by increasing their daily steps and fitness goals,” said HCC Chief Executive Officer Jim Hart. “We value the health and happiness of our employees. It was amazing to see how the competition sparked their motivation and excitement. I hope we inspired other companies to do the same.”

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com.

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventas, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.

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Hart Healthy Challenge- Changing Hearts and Lives

The Hart Healthy Challenge has officially come to an end. Ben Blaylock took first place with Janice Boyd stepping in at a close second.

In honor of Heart Month and in an effort to promote healthy lifestyles and interactions between the team, we challenged our staff to a friendly competition in February. Using Jawbone UP24 devices to track steps, everyone attempted to reach and surpass daily goals of 10,000 steps recommended by the American Heart Association. Together, our team walked 3.4 million steps during the month-long challenge!

We value the health and happiness of our employees, and it was amazing to see how the competition created a natural motivation in the team to move more. Everyone “won” something this past month by increasing their daily steps and fitness goals.

As part of the first-place prize, Ben received $2,000 to donate to his charity of choice, Operation Homefront. Based in Ben’s hometown of San Antonio, Operation Homefront provides emergency assistance to service member’s families and wounded vets. The charity is close to Ben’s heart since many of his family members currently serve or have served in the military.

Janice Boyd earned second place in the challenge and also received $500 to donate to the charity of her choice, Morning Dove Therapeutic Riding Inc. Morning Dove helps people, primarily children, to work with physical and emotional challenges. As an animal lover and owner of two horses, Janice understands the healing impact horses have on people and was thrilled with the opportunity to give back to such a deserving organization.

Ben set a New Year’s resolution in January to get back in shape. After a few weeks, he hadn’t made the progress he was hoping for, so he decided to sign up for a half marathon called the “Alamo 13.1” in San Antonio. At the same time, he was asked to join the “Hart Healthy Challenge” and the timing was perfect! Training for the half marathon and aiming to win the Hart Healthy Challenge, Ben was more motivated than ever and lost 20 pounds in just a few weeks!

“This wouldn’t have happened without the challenge,” Ben said. “Seeing the rest of the team’s activity motivated me to surpass the step goal every day. All the walking strengthened my legs, making a huge difference in my training.”

Similarly, Janice found an increased motivation to exercise because of the Hart Healthy Challenge. She became aware of sitting for too long and would do anything to achieve her daily step goal such as walking the dog, jogging in place, walking on the treadmill, doing jumping jacks and sometimes just running around the house.

“I’m active by nature,” Janice said. “But the Hart Healthy Challenge made me more conscious of being still and drove me to move more than usual.”

The other team members were close behind Ben and Janice and we’re proud of everyone for pushing their limits, to not only increase their health, but also give back to a bigger cause! Many thanks to the team! We hope this challenge inspired not only our staff, but other companies in our industry to put the health of their employees first.

 

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Sr. Clinical Research Associate Patti Lawrence Proctors Insertion of Sentry IVC Filter

Screen Shot 2016-02-10 at 12.49.44 PMWe pride ourselves on having clinical research associates (CRA) like Patti Lawrence, who go above and beyond during clinical trials. When Hart Clinical Consultants (HCC) was contracted by NOVATE Medical Ltd. to proctor physicians during the Sentry IVC clinical trial, CRA Patti Lawrence was called in to lead. Patti’s past experience in cath labs and knowledge of surgical etiquette made her the perfect CRA for this trial. Throughout the case, she guided physicians through procedures and, with little notice, made herself available to assist the sponsor at various U.S. locations as needed.

According to NOVATE, the bio-convertible Sentry IVC filter is designed to provide protection from PE during the period that a patient is at risk, and then bioconvert to a non-filtering configuration after a minimum of 60 days. This feature removes the requirement for an additional interventional procedure to retrieve the device. In addition, Sentry has a cylindrical frame that is designed to reduce the reported complications of existing IVC filter technologies, including tilt, migration, fracture, and vessel perforation. The procedure requires insertion of the device into a patient’s inferior vena cava, a large vein that carries deoxygenated blood to the heart and is designed to filter for blood clots so they don’t migrate to the lungs.

This is currently the only known medical device that actually bioconverts inside the body, meaning it can change once inside to react to its environment. It is a game changer.

Testing new devices and performing investigational procedures on patients can be stressful. In many instances, we must make ourselves available at a moment’s notice to catch a plane and head to a site. This is what makes HCC proctors unique, our ability to accommodate the sponsor when timing is critical to the success of their clinical trial.

We are always thrilled to get feedback from our clients and were pleased when NOVATE had only praise for their experience with Patti. “Patti’s knowledge and clinical experience has served us well. Not only is she confident, but she portrays that confidence and knowledge to those she comes in contact with. You have a gold mine.” What a ringing endorsement!

Patti Lawrence is one of the reasons we are unique among other CROs. Like Patti, each member of the HCC team has practical, hands-on, clinical expertise and proficiency in clinical trial operations. This is not the norm. This unique combination allows study sponsors to focus our resources where they are needed most at various times throughout the trial – whether that be in device training, case proctoring, site management or study monitoring. This reduces the number of committed staff for completing trial activities and often ensures the same person will be the sponsor’s point of contact throughout each trial.

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Hart Healthy Challenge: Get Active. Give Back.

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February is Heart Month, and in support of cardiac-health recognition, Hart Clinical Consultants (HCC) is getting active and giving back. By now, the New Year resolution hype is dying down and we are settling into 2016. Our goal is to remind everyone of one important resolution: be kind to yourself. Yes, that’s right! Let 2016 be the year where you step outside the chaos of life and focus on taking care of YOU!

To promote healthy living, we kicked off our Hart Healthy Challenge yesterday, February 1. HCC staff members are using Jawbone UP24 devices to track their steps throughout the month in a friendly competition. We are all making strides to walk, run, jog, hike, swim and bike more to show the effect an active lifestyle has on a healthy heart. Steps will be tracked on a daily basis and the top stepper at the end of each week will be recognized with a reward for their hard work.

For the grand finale of our Hart Healthy Challenge, the staff member who accumulates the most steps for the month of February will be awarded a $2,000 donation to give to their cardiac-related charity of choice. UPDATE:The second place stepper will be awarded $500 to donate to their cardiac-related charity of choice.

As the month progresses, watch our Twitter feed for updates on the HCC team’s progress and weekly steps! Get involved by sharing your own fitness progress using #HartHealthyChallenge. Even better, consider starting your own “Healthy Heart Month” challenge in your office. And remember, get moving for a healthier heart and a happier body!

Updated: Feb. 11, 2015

Hart Clinical Consultants Experiences Rapid Growth, Doubles Staff

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Stan Reaves Also Named Chief Operating Officer

ATLANTA (January 13, 2016) – Hart Clinical Consultants (HCC), a specialized and adaptable Clinical Research Organization (CRO) that conducts and manages all aspects of novel medical device and pharma clinical trials, has announced it has more than doubled it’s staff over the past six months.

The expansion has brought with it changes to HCC’s executive team. HCC’s former Director of Business Development Stan Reaves, has been promoted to chief operating officer. As COO, Reaves will lead HCC’s national consortium of highly-trained clinical research professionals in providing study sponsors with comprehensive regulatory and clinical support services, including case proctoring, monitoring and audit functions. He is also responsible for HCC’s project management and training programs.

Stepping up to fill Reaves’s shoes in the business development role is Patric Mercer. Mercer’s primary focus as manager of business development is growth and oversight of sales and marketing operations for HCC and assisting with clinical trial operations. Prior to joining HCC, Mercer was a practice administrator and clinical research manager for SleepMed, Inc., where he was responsible for day-to-day operations of SleepMed’s clinical facilities and all aspects of its clinical trial operations.

“We are extremely grateful to have been able to acquire such industry-leading talent over the past several months,” said HCC CEO Jim Hart. “It makes our national network of clinical trial professionals even stronger.”

Within the past six months, HCC also added 11 senior clinical research associates (CRA’s) to it’s ranks, to include: Kari Anderson, Jill Barnes, Janice Boyd, Beth Davis, Cheryl Fink, Helen Gleason, JoAnn Key, Larry Lobacz, Bryan Petrisko, Susan Wilson and Carol Anne Yarbrough. HCC’s senior CRA’s are the company’s back bone and are responsible for a host of integral duties, including procedure proctoring, site management and monitoring as well as working directly with sponsors/clients – all to ensure compliance with clinical trial protocols and the scientific integrity of all data collected.

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventus, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

HCC Welcomes Anderson as Sr. Clinical Research Consultant/Sr. Research Specialist

ATLANTA – Feb. 2, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that Kari S. Anderson, Ed.D, MSN, RN, CCRAhas joined HCC as a senior clinical research consultant and senior clinical research specialist. In this role, Dr. Anderson will manage all aspects of clinical trial operations and provide training support for innovative medical devices and procedures.

An accomplished educator, medical affairs specialist and experienced clinical research associate (CRA) with more than 20 years of clinical experience, Dr. Anderson has demonstrated accomplishments in clinical monitoring, project management, creative instructional strategies, and global clinical research and development. She has been recognized for exceptional collaboration and leadership skills, cross-functional team development, and innovative problem solving aptitude.

With extensive device and pharmaceutical experience in multiple therapeutic areas, Dr. Anderson was most recently a regional CRA for Anderson Clinical Consultants inWestminster, MD. In this role, she was responsible for negotiating contractual agreements to maximize value, cost effectiveness and strategic alignment; monitoring all phases of medical device and pharmaceutical clinical trials; and monitoring assigned clinical sites to ensure all study activities were conducted efficiently, meet enrollment goals and were in compliance with all applicable regulations. She also helped develop monitoring and communication best-practice tools.

Dr. Anderson also held positions with Abbott Medical Optics in Santa Ana, CA as east coast regional manager and principal CRA, and at Abbott Laboratories in Abbott Park, IL as senior clinical manager, outsourcing.

Dr. Anderson received her Bachelor of Science in Nursing from the University of Minnesota and her Master’s of Science in Critical Care Nursing from Duke University. She earned her Doctorate in Adult Education from North Carolina State University.

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 About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.

Hart Clinical Consultants Welcomes Barry as Senior Clinical Specialist/Research Associate

ATLANTA – Jan. 21, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that William Barry RN, CCRA has joined the organization as a senior clinical specialist/research associate. Mr. Barry will manage all aspects of clinical trial operations and proctors procedures for innovative medical devices and operate out of the organization’s headquarters in Atlanta.

Prior to joining HCC, Mr. Barry was with Abbot Vascular for nearly 14 years, serving in various roles including clinical operations manager, field clinical research associate, territory manager and clinical coordinator and manager. In his most recent role, he was responsible for hiring, training and managing a group of 5-8 Field CRA’s in the U.S. Mr. Barry also was responsible for project management, protocol writing/review and CRF design. During his time with Abbot Vascular, Mr. Barry oversaw numerous areas including being in charge of sales and training, site assessments, site initiations, monitoring, case proctoring, site support for AV clinical trials and more.

Prior to joining Abbot Vascular, Mr. Barry worked as a staff nurse at Atlanta Medical Center/Georgia Baptist. He holds an associate’s degree in nursing from DeKalb University and a Bachelor of Science degree in biology from Oglethorpe University. In addition, Mr. Barry received EMT and LPN training from the United States Army.

To learn more about HCC’s full team of medical professionals and services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com