OHSU

Study Coordinator Training

Study Coordinator Training Series

The OHSU Knight Cancer Institute and the Oregon Clinical and Translational Research Institute (OCTRI) will be offering a series of classes for OHSU Study Coordinators. The classes are designed to provide study coordinators with working knowledge of OHSU research policies and operations. The goal is to further the development of highly skilled study coordinators at OHSU. 

Wait-list registration is open to all OHSU employees currently working as Research Coordinators, although previous completion of the Quarterly Clinical Research Coordinator Workshop is highly encouraged.

Workshops 

  • Essential Regulatory and Source Documents
    Date:  TBA
  • Writing and Obtaining Informed Consent
    Date:  TBA
  • Analyzing and Implementing a Research Protocol
    Date: TBA

Registration

  • A completed registration form is required.
  • Registration is open to all OHSU employees currently working as Research Coordinators, although previous completion of the Quarterly Clinical Research Coordinator Workshop is highly encouraged.
  • Workshops are limited to 30 students and will be offered on a rotating basis. 
  • Registration is on a first come, first serve basis. 
  • Continuing Nursing Education Credits will be available for the classes. 
  • Questions should be directed to Jennifer Kepler at keplerj@ohsu.edu.

Writing and Obtaining Informed Consent

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This 4 hour workshop is designed to provide guidance and practical tips for writing and obtaining informed consent from research participants.   The workshop involves lecture, examples, and an exercise on obtaining informed consent.

Class objectives include:

  • How to pull information from the protocol when writing the consent document
  • Choosing the appropriate liability language
  • Choosing the appropriate consent templates and HIPAA forms
  • How to obtain informed consents from a variety of study subjects (decisionally impaired adults, child assent, adults with limited English proficiency)

Registration: Contact Jennifer Kepler for questions.  Complete registration form required.

Date: TBA
Time:  TBA
Location:  TBA
Course materials will be available closer to the workshop date.

 

Analyzing and Implementing a Research Protocol

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This 4 hour workshop is designed to provide an in-depth discussion of the role the study coordinator plays in analyzing and implementing a research protocol at OHSU.  The workshop involves lecture, examples, and hands-on protocol analysis exercise.

Class objectives include:

  • How to identify key information in a research protocol
  • Differences between a clinical research protocol and a grant
  • How to identify safety procedures and distinguish standard of care from research
  • How to address logistical concerns (location, personnel, OHSU research forms)
  • Epic and research records

Registration: Contact Jennifer Kepler for questions.  Complete registration form required.

Date: TBA
Time:  TBA
Location:  TBA
Course materials will be available closer to the workshop date.

 

Essential Regulatory and Source Documents

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This 4 hour workshop is designed to instruct study coordinators on the essential documentation needed while conducting the research study for your regulatory and subject files.   The workshop involves lecture, examples, and an exercise on identifying and generating appropriate source documentation. 

Class objectives include:

  • What information is needed in your regulatory files
  • How to adequately record study data/adequate case histories
  • When to use “Notes to File”
  • Epic and research records

Registration: CLOSED.

Date: TBA
Time: TBA
Location: TBA

Course materials will be available closer to the workshop date


Regulatory Documents and Submissions

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This 4 hour workshop is designed to provide guidance and practical tips for preparing IRB, OCI and OCTRI applications.   The workshop involves lecture, examples, and exercises on how to complete regulatory submission documents. 

Class objectives include:

  • How to complete the Clinical Billing Schedule and Nursing summaries
  • How to complete the PPQ
  • When is a modification to the protocol needed?
  • Tips for completing an initial IRQ, continuing review, modification, AE/UP, and protocol deviation in the eIRB

Registration: Not available at this time.

Date: No date available at this time.
Time:
Location:
Course materials will be available closer to the workshop date.

Registration

Please complete the registration form for each of the classes you would like to attend.