Practice Root Cause Analysis at SCORE Half Day Seminar

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The registration deadline to attend the 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half Day Seminar is quickly approaching.  This year’s seminar will feature a simulation of root cause analysis, a methodology to review adverse events, identify key causes and contributing factors and implement system-based solutions. Recent changes to guidelines for investigation and prevention of non-compliance in clinical trials require sponsors and often research teams (study coordinators and research nurses) to be able to perform root cause analysis.

Clinical trial protocols are designed to examine specific scientific questions while minimizing risks to patient safety and maintaining data integrity.  Clinical trials have become increasingly large and complex over the past few decades. It is not uncommon for a trial to have many sites that span the nation or the globe and study teams that may change in personnel during the trial. This increased complexity leads to greater risk of errors and non-compliance, resulting in deviations from the protocol.

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, has set expectations that all sponsor or clinical research organization (CRO) personnel should review the monitoring plan and be prepared to perform a root cause analysis, and to implement appropriate corrective and preventative actions when deviations occur.

When things go awry in clinical research, it is essential to understand the underlying cause(s) of the error or protocol failure. Root cause analysis gets to the core of the issues, which are often related to system defects in communication, policies and processes, environment, information management and/or human resources. Depending on the root cause identified, system-based solutions are designed to reduce or eliminate the risk of the event recurring.

One thing to keep in mind is that, by their very nature, root cause analyses are not one-size-fits-all. The nature of issues and the optimal intervention will vary from site to site and from study to study. This is why it is important to do a thorough assessment of each critical issue as it arises and devise targeted solutions to prevent future issues.

To learn more about root cause analysis and the expectations for study coordinators and research nurses, register for the SCORE Half Day Seminar.

The seminar will be held on Tuesday, June 7th in the Ryan Case Method room in the URMC with live streaming available at an overflow site. Parking will be available for non-UR attendees for $6 fee.

For more information, please contact SCORE@urmc.rochester.edu.

SCORE Half-day Seminar: Call for Posters!

Confident businesswoman giving a presentation at white boardResearch study coordinators and project nurses are invited to register and submit posters for the CTSI-sponsored 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half-Day Seminar taking place at the URMC on Tuesday, June 7th.

The SCORE Half-Day Seminar is a morning of learning and professional development for research personnel. Researchers, study coordinators, and project nurses are encouraged to participate in discussions about autonomous motivation  and supporting psychological needs in the workplace,  learning problem-solving skills, such as root cause analysis, to address errors and reduce risk, understanding how to plan, implement, and maintain standard operating procedures and learning how “being mindful” promotes resilience and well-being.

Study team members interested in presenting a research-related poster must submit their entry by Friday, May 6 at 4pm. The poster session will kick off the seminar from 7:30 to 8:00am on Tuesday, June 7. Presenting authors must remain by their posters for the 30 minute poster session and posters will remain on display throughout the half-day seminar.

All attendees (nurses and non-nurses) can earn 3.83 continuing education contact hours from the University of Rochester Center for Nursing Professional Development, which is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

The seminar is presented by SCORE and the University of Rochester School of Nursing, and sponsored by the Association of Clinical Research Professionals and CTSI.

For further information about poster submissions or to register for the seminar on-line by June 2, click here.

Please contact SCORE@urmc.rochester.edu, with any questions.

 

UR Connected: Linking Researchers and Research Coordinators at UR

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Are you a research coordinator in need of a job? Or a researcher looking for a coordinator?

UR Connected is like Monster.com for research coordinators.  Like Monster, UR Connected is a web application that allows job seekers and employers to find one other – only in this case the job seekers are all research coordinators and the employers are research investigators at the University of Rochester.

Within UR Connected, research coordinators can post their qualifications, advertise availability for new or additional projects, browse job titles and HRMS IDs for posted jobs, or browse opportunities to contribute to in their spare time. On the other hand, research investigators or hiring managers can search for coordinators based on their qualifications and availability, post HRMS jobs, and advertise opportunities that are more limited than a posted position in HRMS.

Noreen Connolly, M.S., J.D., clinical research coordinator for the Strong Epilepsy Center and Department of Anesthesiology and advocate for UR Connected, has used the system from both perspectives: job seeker and employer.

As a self-proclaimed life-long learner Connolly loves the opportunity UR Connected provides for research coordinators to “step to the side and learn something different, learn a new field, and to continue to grow” by picking up jobs outside their area of expertise.

Like Connolly, coordinators can also fill in the lulls in their full-time work with part-time or temporary jobs on UR Connected. These jobs offer an opportunity for research coordinators to acquire additional working hours and gain a little expertise in an area outside their regular work without having to completely change jobs. This application also makes it easier for out-of-work research coordinators to find full-time positions of interest to them. This helps the university retain a very good, experienced pool of coordinators and reduces the need to constantly train new people.

Connolly says she found the application to be very easy to get into and easy to use. Her advice: “Don’t hesitate to use UR Connected. It’s very simple and it’s worth the few minutes of your time and effort.”

She also recommends periodically updating your profile. If you are a research coordinator or investigator who has a profile or posting in UR Connected, take a moment to ensure all of your information is current and correct. It could be the difference between finding that golden opportunity or missing it.

If you are a research coordinator or investigator interested in more information visit UR Connected, or send your questions to researchhelp@urmc.rochester.edu.

SCORE: Helping research coordinators connect and learn

by Nancy Needler, Special to the CTSI Stories Blog

Are you a research coordinator? This article is for you.

Do you know a research coordinator? Then please, pass this along.

Principal Investigators and research team members rely on coordinators every day. Coordinators impact the lives of research subjects and assist to provide the foundation behind the science data in the development of new clinical procedures, drugs, devices and technology to improve health care.

As a result, the University continues to recognize the professional role of the coordinator, and the CTSI is here to provide support.

SCORESCORE

The Study Coordinators Organization for Research & Education (SCORE) is a forum organized for coordinators where participants meet to share information, to collaborate to develop tools and practices, and to learn of University processes related to human subject research management. Providing support and regular networking opportunities for University research coordinators and staff, SCORE monthly events include presentation of resources and services needed for coordinating research, open discussions to share best practices and to discuss and identify resolutions to barriers in everyday study management activities.

To further support coordinators helping each other, a coordinator discussion listserv is also being developed. Soon coordinators will have this online forum for discussions with peers.

(This past June, SCORE, under the support of the CTSI and SON with OHSP and ACRP hosted the annual SCORE Half-Day Seminar for coordinators. The event, its 7th year, offered continuing education contact hours, was attended by 143 people, and 100% of those who responded to the evaluation rated the overall program as “good” to “excellent/high.”)

SCORE events are held monthly. Interested? Want to be engaged? What to learn what’s around the corner? Be sure you are on the SCORE distribution list – contact SCORE@rochester.edu. Protect your time now to attend future networking and educational events. To learn more, visit the SCORE website.

SCORE’s next forum event is scheduled for September 10th and will be listed on the CTSI calendar.

Research coordinator job series

Coordinators: You are special! This career is growing quickly and is recognized as a certified profession by the ACRP and SoCRA. A preparation review course is offered at the start of each year to the applicants for certification examinations. The Office for Human Subject Protection and the CTSI facilitate this successful course. Over the past 2 years, 33 students took the course, 12 of which were applications for taking the exam. All 12 applicants have passed their certification exam. The University encourages and supports recognition of your skills and experience through certification.

In 2014, the University, in a collaborative initiative with stakeholders (which included coordinators, hiring managers, human resources and CTSI leadership) formalized the coordinator career path in the three-level Human Subject Research Coordinator job series. When positons need to be filled, hiring managers and human resource business partners turn to this job series. Coordinators now have a career path designed specifically for their role.

Hiring managers are using UR Connected to advertise and connect with potential new hires.  Hiring managers continue to examine the information in listed coordinator profiles and contact coordinators for available positions.  Coordinators – consider entering or updating your profiles in this connection system.

Study Coordinators – your dedication to your profession is recognized.  Your knowledge is sought to improve study management operations.  You are invited to connect and learn by participating in SCORE.  For more information contact:  Together, we can raise research coordination to the highest order.

 

Research Coordinators Wind-up and SCORE!

SCORE– Nancy Needler, BS, CCRC, Research Subject Advocate

It takes a team to conduct research and UR research coordinators are on the field. Did you know that research coordinators meet every month to share information, collaborate, and learn about University processes related to human subject research? SCORE – the Study Coordinators Organization for Research & Education – is a CTSI-sponsored group which supports research coordinators.

SCORE attendees gain firsthand knowledge of University regulatory updates and best practices. Importantly, participants have a voice in what they want to learn from meetings and from each other.  Here are a few examples:

  • The December 12th meeting in the Saunders Research Building, room 1.416 at noon, is a special one. Christopher Hoolihan, Rare Books and Manuscripts Librarian from the Edward G. Miner Library, will present, “A Photographic History of Research at the Medical Center, 1925-45.”
  • In 2014, SCORE will team up with the Office for Human Subject Protection to present a two-part mini-series entitled, “Building a Coordinator Tool Kit for Research Quality,”  in which University quality improvement teams will share their processes and pearls of wisdom.  Attendees will learn from the best.
  • SCORE offers mentoring services – one-on-one support and encouragement to new coordinators or those who have new responsibilities. SCORE’s mentors are experienced coordinators who share their expertise with others for one particular task or for an extended period. To request a mentor, please e-mail SCORE.

Take a time out to network with research staff and have some fun at our December meeting. To receive event notices and other news, email SCORE or subscribe to the CTSI Weekly Update. Research coordinators don’t need to play soccer or even hockey to SCORE!