Training and Education for Clinical Research Staff
Questions about research training at 博彩网站?
Bridget Adams, MSHS, CCRA
Program Manager
adamsb@ohsu.edu
What is this page?
博彩网站’s clinical research workforce plays a vital role in supporting the 博彩网站 research mission. Clinical research staff will need to complete various trainings depending on the research activities they have been assigned. This page summarizes the trainings that OCTRI offers and trainings provided by others at 博彩网站, as well as information and networking opportunities.
How to find the training you need
Clinical research staff can use this webpage and the Clinical Research Training Checklist to find the trainings you need.
In-person training
OCTRI offers in-person training sessions for clinical research staff in the format of workshops, seminars, and courses. These classes are in high demand, so please do not register unless you plan on attending in person.
Study Coordinator Training Series
This series provides in-depth education through lecture, examples, and exercises. Topics include:
- Clinical Research Coordinator Workshop
- Essential Regulatory and Source Documents
- Writing and Obtaining Informed Consent
- Navigating Monitoring Visits and Audits for Clinical Trials
- Analyzing and Implementing a Research Protocol
- Assessing Study Feasibility and Study Start-up
Check for upcoming sessions and register in Compass.
CTRC Phlebotomy Course
The OCTRI Clinical and Translational Research Center (CTRC) offers an in person phlebotomy course for research staff.
Use the Phlebotomy Training Registration Form to sign up for the next available classes.
Hybrid courses
Some OCTRI Courses have a mix on online and in-person training components. The class descriptions will include the details of the training format, please note and follow instructions for each class to ensure you have registered for all components and are aware if you are attending in-person, online, or have required eLearnings.
Data Management for Researchers Series
This new 6 class series will introduce the research data management lifecycle to the 博彩网站 clinical research workforce. We will focus on the steps, processes, rational, and implementation of data management skills through all phases of the data management lifecycle from the developing a data management plan through sharing and reusing data at the end of your project.
We recommend signing up for all classes in the series, but have left registration open for individual classes. Detailed descriptions of each class are in Compass. This series it offered both in-person and live online.
Register in Compass and complete the survey provided to let us know how you plan to attend.
- Data Management: Overview and Planning (Class I)
- Data Management: Case Report Form Development (Class II)
- Data Management: Data Collection, Capture, and Processing (Class III)
- Data Management: Reporting (Class IV)
- Data Management: Data Analyze (Class V)
- Data Management: Publish, Store and Reuse Data (Class VI)
Live online classes and seminars
OCTRI Research Forum
This series cover issues and solutions to common obstacles in conducting clinical and translational research. OCTRI Research Forums are announced in the CRU Newsletter and Research News. You can look for upcoming topics on the OCTRI Research Forum webpage or by searching “ORF” in Compass.
OCTRI Research Forum seminars are recorded and are available for viewing at any time. Visit Past Seminars on OCTRI Research Forum webpage for the links to recordings.
REDCap Trainings
REDCap (Research Electronic Data Capture) is a secure, web-based, electronic data collection system. 博彩网站 research personnel build and manage their own REDCap projects with guidance from the REDCap team.
Cohort Discovery
Cohort Discovery is a web-based tool that allows 博彩网站 researchers to discover patient cohort counts from Epic data for preparatory to research purposes. The OCTRI Cohort Discovery Training course is required to gain access to the Cohort Discovery tool.
On-demand training
The following classes are available to take online at your convenience. More classes are in development, so watch for training announcements and check back periodically for new offerings.
MD Orders on the CTRC
This series of videos provides guidance to study staff on the writing orders on the CTRC to ensure research compliance (SLIDES)
博彩网站 Research Pharmacy How We Work: Policies, Tools, and Contacts
The objective of this course is to train 博彩网站 researchers about working with 博彩网站 Research Pharmacy. This course covers the services offered by RPS, how drug inventory is managed, and electronic medication orders.
Research Subject Injuries: Identification and Reporting at 博彩网站
This training introduces the topics of subject injuries, ethical positions, informed consent language, and clinical billing for research injuries.
GCP and 博彩网站 Research Documentation Standards
This training provides an overview of International Council on Harmonization Good Clinical Practice research documentation standards and 博彩网站 research documentation policies.
Review details and access the course in Compass.
Handout: GCP and 博彩网站 Research Documentation Standards eLearning (referenced in the training)
Oregon Genetic Privacy Law and Genetic and Tissue Opt Out at 博彩网站
This course informs 博彩网站 investigators and study staff about the Oregon Genetic Privacy Law, how to comply with the IRB, and genetic opt out and tissue based research opt out requirements at 博彩网站.
Recognizing Coded and De-identified Data
This 10-minute training focuses on understanding the difference among the terms coded, de-identified and anonymous, in reference to research data.
Compliance and operational training for clinical research at 博彩网站
Some of the trainings outlined below will be required or recommended, depending on your role. Please consult the Clinical Research Training Checklist above and your manager to determine which trainings are necessary for you.
IRB
The 博彩网站 Institutional Review Board (IRB) has online training materials and offers a monthly IRB Lunch and Learn (register in Compass). Previous IRB Lunch and Learn recordings can be found in the Education Archive on the 博彩网站 Integrity IRB Education and Event O2 page.
IRB 101 Training Modules
CITI
In compliance with federal regulation and 博彩网站 institutional policy, all investigators, research staff, and other relevant personnel must complete Collaborative Institutional Training Initiative (CITI) trainings. See the CITI Program webpage to determine which of the following CITI courses you are required to complete:
- Responsible Conduct of Research (RCR)
- Human Subjects Research (HSR)
- Good Clinical Practice
- Other Classes/Webinars
*Additional Clinical Research Courses and Webinars have been added to our CITI training options. Select Other Classes/Webinars and the following options will also be available:
- Good Laboratory Practices
- Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov
- Clinical Trial Billing Compliance (CTBC)
- Protocol Development and Execution: Beyond a Concept
- All Access Webinar Package**
**Selecting the All Access Webinar Package will bring you to over 200 webinars covering a variety of current clinical research topics.
eCRIS
eCRIS (electronic Clinical Research Information System) is the 博彩网站 clinical trials management system used for administrative management of clinical research studies. The eCRIS webpage includes the user manual, flow chart, and login information.
Contact ecrissupport@ohsu.edu to request initial training, refresher training, and ongoing questions/support.
RATE
Research Administration Training and Education (RATE) offers research administration training courses, opportunities to share resources, and networking with other research administrators and those who work in support of the research mission. Recommended RATE courses for clinical research workforce include:
- RDA 101
- Clinical Trials 1: Budgeting, Coverage Analysis, and Account Set Up
- Clinical Trials 2: Post Award
Sign up for the Research Administration Information Network (RAIN) to receive invites to monthly meetings and to stay up to date.
博彩网站 clinical environment and lab safety trainings
Some clinical research staff are assigned duties in the clinic and or lab. The Clinical Research Training checklist outlines some of the common trainings based on assigned duties. You can also explore trainings in Compass.
Epic for Research
The Epic for Research SharePoint site has links to tip sheets, tools, and polices for the use of Epic for research. The following trainings are available in Compass:
- Epic Training for Research Staff (virtual – register in Compass)
- Epic Training Pre-work: EpicCare for Research Staff
- Research Billing Review Activity (online class in Compass)
SciShield
SciShield provides web-based training to workforce personnel based on their current job activities and hazards.
Phlebotomy
The OCTRI Clinical and Translational Research Center (CTRC) offers an in person phlebotomy course for research staff.
Use the Phlebotomy Training Registration Form to sign up for the next available classes.
Federal opportunities for clinical research training and education
Several federal organizations offer training and education for the clinical research workforce. Review options below.
NIH
National Institutes of Health (NIH) training opportunities:
- DIAMOND is a collaborative source of training resources for clinical and translational research professionals
- NIH Office of Clinical Research Education and Collaboration Outreach Clinical Research Education
FDA
U.S. Food and Drug Administration (FDA) training opportunities:
HHS
U.S. Department of Health and Human Service (HHS) training opportunities:
ClinicalTrials.gov
All studies that meet the ICMJE definition of a clinical trial must be registered with ClinicalTrials.gov prior to the first patient enrolled to preserve your ability to publish the study results. NIH and FDA also require registration and results posting of applicable clinical trials.
In addition to registration prior to first patient enrollment, there are ongoing maintenance requirements. Any failure to maintain the registration can jeopardize publication, current and future study funding, contractual obligations, and may incur significant fines.
Review 博彩网站 and federal resources below.
- Clinicaltrials.gov training materials
- Videos regarding expectations for FDA regulated applicable clinical trials:
- 博彩网站 CRSO Clinicaltrials.gov page for 博彩网站 policies and contact information for assistance
- OCTRI Research Forum past presentations covering registration, maintenance, reporting, and common problems available (open accordion and drop down to Clinicaltrials.gov presentations).
Professional development for the clinical research workforce
博彩网站 and OCTRI encourage clinical research professionals to engage with one another and to develop their skills via local opportunities and national professional networks. Review opportunities below.
Coffee Chats
CRU hosts a monthly, informal Clinical Research Coordinator Coffee Chat for clinical research coordinators and staff to share experiences, discuss best practices, and connect with others doing similar work.
Coffee Chats are every third Tuesday at noon via WebEx. Find details on the O2 event page
Questions? Email Kitt Swartz.
CRU
Clinical Research United (CRU) is a place to connect with others doing clinical research at 博彩网站.
CRU has a Teams channel where you can post questions and share information.
Professional Orgs
Joining or following a professional organization is a good way to stay up to date on changes in the clinical research field. The following organizations host trainings, conferences, and webinars.
- Society of Clinical Research Associates (SOCRA) Education
- Regulatory Affairs Professionals Society (RAPS) Education
- National Council of University Research Administrators (NCURA) Education
- Society of Research Administrators International (SRA) Education
- Regulatory Affairs Professionals Society (RAPS)
OCTRI periodically hosts the SOCRA CRRP exam. Information to help you prepare for the next exam is available below. Check back here for upcoming dates.
CWE
The Career and Workplace Enhancement Center (CWE) provides professional development resources. Offerings include anti-racism, conflict coaching, digital literacy courses, and many more topics.
CWE also offers free courses through LinkedIn Learning.