January 2019
IRB Quarterly News
|
|
 |
Lifetime Achievement Award
Presented to
Lynn Meyer
|
|
|
|
Lynn started IntegReview IRB 20 years ago with just 1 employee and 1 IRB and the need for a 2nd IRB was comprised within the 1st year of business. Today, IntegReview boasts 5 IRBs, each meeting one day per week with a total of 26 IRB Members and 39 IRB administrative staff.
"Success is a clear reflection of the effort, pride and passion with which a person lives", and Lynn has clearly proven these 3 attributes to ring true. By sharing her experience she leaves a legacy of success.
IntegReview thanks Lynn for her 20 years of visionary guidance and outstanding leadership and wishes her the best in her future, which is no doubt, to be filled with
grand adventures
.
|
|
|
|
Celebrating 20 Years
of Service!
|
IntegReview has been lucky to have worked with such exceptional IRB Members over the years, and we would like to recognize those IRB Members that have consulted with us since the very beginning!
Congratulations to these six IRB members for their 20 years of service and dedication to IntegReview IRB.
|
|
Fred Kopec, J.D., B.A.
Charles Ryan, Ph.D., M.S., R.Ph.
Christine du Castel, M.D.
Susan Parker Ginnings, R.Ph.
*Michael Romain, M.D.
*Marcy Goodfleisch, M.S, M.A.
|
|
Editor's Note
Everyone at IntegReview IRB wishes you a happy 2019 and we hope that you all had a wonderful holiday season spending time with dear friends and family.
Here at IntegReview, we have even more reasons to celebrate the new year! On January 26, 2019 we celebrated our
20
Year Anniversary! We want to thank all of our customers and industry friends for your support and referrals over these past 20 years that have helped our company thrive!
We want to wish a Happy 20th "Work"iversary" to our fearless leader, Lynn Meyer, IntegReview's founder and Managing Partner; a woman whose passion propelled her to make her dream a reality.
Melissa Meyer, CCRP
President, IntegReview IRB
|
|
IntegReview IRB
Career Center
IntegReview IRB is busier than ever and continually growing and we are currently looking for highly motivated people that have the ability to multi-task in a fast-paced environment.
Operations Dept.:
IRB Administrative Associate I
IRB Administrative Associate II
Regulatory Compliance Dept.:
Quality Control (QC) Associate
If you happen to know someone in the Austin area looking for work please send them our way.
To review job descriptions and our application process
CLICK HERE
!
|
|
The Common Rule Changes Are Here....Now What?
On January 19, 2019, the final rule was issued by the U.S. Department of Health & Human Services (HHS) updating regulations to enhance protections for individuals who participate in research. As some of these new regulations under the Common Rule affect how IRBs collect and review information, IntegReview has incorporated some changes to our policies and IRB forms. Click on the link below to learn how IntegReview is complying with the new regulatory requirements and how they may affect the way you submit information to the IRB.
|
|
Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
The FDA regulations (21 CFR 50-56) on human subject protection help to ensure the rights, safety, and welfare of human subjects participating in FDA-regulated clinical investigations are protected, and they generally conform to the HHS regulations at 45 CFR 46 (Common Rule). In an effort to reduce confusion and burden associated with complying with two different sets of human subject protection regulations, the FDA intends to undertake notice and comment rulemaking to harmonize their regulations with the revised Common Rule.
|
|
|
CONGRATULATIONS TO OUR S.T.A.R AWARD WINNER!
Our quarterly S.T.A.R. Award Winners are voted on by their peers, and are recognized for their admirable work ethic and dedication to providing excellent service!
Sylvia Zamarripa
Senior QA Associate
Quarter 1
|
|
|
|
Heavenly Filled Strawberries
Show your Sweetie, your friends or your kids how much you love them
this Valentine's Day by serving this fun, and healthy"ish" treat!
|
|
|
|
|
Jenna Rozacky, CCRP
Assistant IRB Coordinator
As an Assistant IRB Coordinator, Jenna provides assistance to the IRB Coordinators/Co-Chairs with all activities associated with the planning, conduction, and follow-up of IRB meetings, while also processing studies that meet the criteria for expedited review as identified in the Federal Register.
Outside of the office, Jenna likes to travel with her boyfriend, Brad, and spend time with her two cats, Jac & Jasper. She enjoys a good cup of tea, playing video games, attending renaissance fairs (in costume), and fantasy/sci-fi books.
|
|
|
|
Tonya Reed
IRB Coordinator/Co-chair
Tuesday Board
Tonya is responsible for coordinating and facilitating the Tuesday IRB meeting as a voting IRB member, and processing the day-to-day administrative activities that support the IRB. And as IRB Coordinator/Co-chair, she is the main point of contact to clients for the studies in which her board
oversees.
In Tonya's spare time she loves watching movies, cooking, decorating and spending time with her family.
|
|
|
|
|
|
IntegReview IRB will be an exhibitor at the upcoming Global Oncology Site Solutions Summit on February 2-3, 2019 in Austin. Please come by and see us at
Booth 33 to discuss your oncology study needs.
Additionally, if you or someone you know is interested in becoming an IRB (Oncology) Member we would love to speak to you.
|
|
|
|
|
|
|
