New Opportunity -Writing Group for Clinical Research Professionals — Consider sharing your expertise!!!
New 12-week peer-support writing program for educational efforts in clinical translational research developed by Yulia A. Levites Strekalova, PhD, MBA. The goal of the program is to create peer networks and communities and support the preparation of educational manuscripts and conference abstracts.
The essence of the program are weekly zoom calls during which participants will receive very brief writing tips (5-10 minutes), state their writing goals (in chat), write for 30-35 minutes, and exchange feedback (15 minutes). The program is based on the evidence from many similar programs and books and papers written on this topic.
This is of interest to our collective Clinical Research Professionals group for two reasons:
- First, most of you (all of you?) carry on educational activities as part of your direct job responsibilities-when you orient a new study volunteer to the processes of the study team and the protocol, when you inform PIs on the regulations, or when you explain the study to prospective participants. All of these are examples of educational activities.
- Second, many of you have a lot of experience that would be of benefit to others !!!
We would like to organize a writing group specifically for research professionals. If you are interested in working on a short paper or preparing a conference abstract, please email Yulia A. Levites Strekalova,PhD, MBA at firstname.lastname@example.org.
Two more pieces of information.
* Association for Clinical and Translational Science now accepts abstracts and session proposals. Abstract Deadline: December 2.
* Nurse Educator (IF: 1.454) is one potential publication outlet (there are others). NE publishes Brief Reports (1,000 words) and teaching tips (250 words).
Clinical Research Professionals Advisory Council Seminar Series
Join us on the last Friday of the month from noon – 1 p.m. in C1-11, Communicore or Alumni Auditorium for remote participants in Jacksonville. See a list of upcoming presentations below, and subscribe to the CTSI newsletter, Quick Links, for updates about these seminars and other events and opportunities.
If you are interested in Clinical Research Career opportunities please join our supportive Yammer community for ongoing information and opportunities. Yammer is a private microblogging / collaboration platform for social networking at UF allowing members to connect and communicate using an interface that loosely resembles Facebook. This platform is useful in that we can communicate via Yammer rather than a list serve or random emails. You will find will various resources posted there and we will post relevant materials and information on this site going forward and everyone can engage in ongoing discussions.
In order to join please go to Yammer.com and select “Login” in the top right. Then, enter your Gatorlink address (DO NOT use a sub-domain like shands.ufl.edu or you will be directed to another Yammer group). To get set up, you can read more about Yammer here: http://citt.ufl.edu/tools/yammer/. Once you enter your Gatorlink email address, tab and wait for the UF credentialing page to show up. DO NOT ENTER YOUR PASSWORD on the Yammer login page. After a few seconds, you will see the usual Gatorlink login page. Enter your Gatorlink credentials again and you will be directed to the ufl.edu Yammer group.
You can either search for Clinical Research Career Interest using the group name, or email Bob Kolb (email@example.com) to let him know you’re on Yammer, and he will search for and add you.
Experienced research coordinators are in demand both locally and nationwide. Certification can lead to many different career possibilities that can include clinical and commercial applications with greater professional growth and higher levels of pay.
The CTSI Certificate of Basic Coordinator Training provides entry-level education for those who wish to become a clinical research coordinator. Potential students include health professionals working in nursing, nutrition, respiratory therapy, occupational/ physical therapy, or similar allied health fields.
The certificate program consists of two required courses and one optional course. These courses can be taken in any order. Students set their own pace, and most are expected to complete all requirements in approximately two semesters.
For more information, visit https://www.ctsi.ufl.edu/education/research-coordinators/research-coordinator-certificate-program/.
Resources for Clinical Researchers
Online Training Opportunities
Good Clinical Practice (GCP) for Social Behavioral Research
This course is designed for principal investigators. research study coordinators, and other staff involved in social and behavioral research at UF, and is available at myTraining. There are no prerequisites, and the course will require approximately 2 hours, 15 minutes to complete. https://rod.sumtotalsystems.com/ufshands/app/management/LMS_ActDetails.aspx?UserMode=0&ActivityId=30405
CITI Program – Collaborative Institutional Training initiative
You may sign up for CITI Clinical Research Coordinator Training and a variety of other CITI courses via MyUFL.
1. Go to http://my.ufl.edu
2. Log in using your UFL credentials
3. Go to Main Menu > My Self Service > Training and Development > CITI Training
4. On the next Window select “Agree & Continue”
5. Update your contact information, if necessary
6. Click on Main Menu
7. Select “Add a course or Update Learner Groups,” then scroll down to Section 6 and select “GCP for Clinical Trials with investigational Drugs and Biologics (ICH Focus)
8. Press “Submit” at the end of the page
9. The next screen should list courses you are registered in and their completion status
10. Changing your role in your institutional profile can result in changes in recommended courses
Simulation-Based Learning Platforms for Healthcare
Online series for Clinical Research training created by Merck and Syandus Inc.
ACRP eLearning Platform
Sponsored by the Association of Clinical Research Professionals; available to members of ACRP. https://www.acrpnet.org/types/elearning/
Available courses include:
Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review
Theory to Practice: Operationalize Your Clinical Study Protocol
The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential
Site Quality Management Tools: SOPs, Metrics and Training
Risk-Based Monitoring: The Essentials for Investigators
Risk-Based Monitoring: The Essentials for CRCs
Risk-Based Monitoring: The Essentials for CRAs
Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets That Make Sense
Managing Billing Compliance Risks: Navigating Medicare in Clinical Trials
Key Skills for Ensuring Quality Control through Risk-Based Decision Making
Introduction to Clinical Trials
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
ICH Gap Analysis Tool
Good Clinical Practice: An Introduction to ICH GCP Guidelines
GCP Test-Out Challenge
GCP for the Experienced Investigator: Reducing Risk and Avoiding Common Inspection Findings
GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings
GCP for the Experienced CRA: Improving Monitoring Efficiency and Effectiveness
Form FDA 1572: Get It Right the First Time
Ethics and Human Subject Protection
eResearch: Managing Clinical Trials in an Electronic Environment
Certification Exam Preparation – PI
Certification Exam Preparation – CRC
Certification Exam Preparation – CRA
Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA
ACRP Certification Exam Preparation
ICH Gap Analysis Tool: Interactive Content
Certification Exam Preparation: Evaluation