Coordinator Training Checklist - Biomedical

NOTE: This checklist is provided as a guide to facilitate training for study coordinators working in a biomedical setting. Universityrequired training is identified with asterisks in the applicable activities’ description. In some instances the required training
elements are study and/or role-specific; please eliminate and/or insert training elements as required (additional training resources
for your consideration are available in OHSP’s “Study Team Member Training & Resource Reference List” document). In the event
that you are unsure whether the element is required, please contact the element’s department/division directly (e.g., if you are
unsure whether HIPAA Privacy and Security training is required, please contact the Research Privacy Officer directly). If you would
like guidance on developing departmental and/or study team training standards, contact Kelly Unsworth at (585) 275-5244 or
[email protected]
Study Coordinator Basic Training Checklist – Biomedical Research
Employee Name:
Job Title:
Job Code:
Human Subjects Research Training (CITI Program)
* Required prior to conducting any human subjects research
OHSP Education & Training Framework
 OHSP Orientation to Conducting Human Subject Research
 OHSP Research Boot Camp
 OHSP Core Training Module 1: Study Design
 OHSP Core Training Module 2: PI Oversight
 OHSP Core Training Module 3: Financial Management
(Note that this module consists of ORPA Blackboard Courses CT-01 and CT-03
listed below.)
 OHSP Core Training Module 4: Study Operations
 OHSP Core Training Module 5: Recruitment & Retention
 OHSP Core Training Module 6: Informed Consent
 OHSP Core Training Module 7: Investigational Products
 OHSP Core Training Module 8: Subject Safety
 OHSP Core Training Module 9: Essential Documentation
 OHSP Core Training Module 10: Quality Management
ROSS (RSRB Online Submission System) Training
Training modules are provided on the OHSP website. Alternatively classroom training
is available the 3rd Monday of every month from 2-3pm in the OHSP Office (contact
Suzanne Flanigan at x53050 on global to sign up)
ORPA Blackboard Course: Overview of Clinical Research Billing Policy
and Standard Operating Procedures (Course CT-01)
ORPA Blackboard Course: Clinical Trial Finance – Budgeting and
Negotiation (Clinical Trial Finance Course CT-03)
Note that this course is targeted for individuals dealing with clinical trial budgets. As
such, applicability may be depend on departmental roles and will not likely apply to
ORPA Blackboard Course: UR Conflict of Interest Policy (Course UR
ORPA COI Policy)
Page 1 of 2
HIPAA Privacy and Security Training
* HIPAA Privacy and Security training may be required based on an employee’s role
within the University. Requirement information can be found here: Link
Orientation Requirements for FDA Investigational New Drug
Applications & Orientation to Medical Devices and the Requirements
for FDA Investigational Device Exemption Applications (CTSI FDA
* Required for investigators prior to any IND or IDE submissions (training is optional,
but strongly recommended for study team members working on FDA-related aspects
of the study
Radiation Safety Training
* Required for all prospective users of radioactive material.
Environmental Health & Safety: OSHA Required Training
* Required for all staff working in labs or supervising lab personnel (customized
training for Clinical Lab Personnel, Phlebotomists & Clinical Study Coordinators and
Research Lab Personnel)
Environmental Health & Safety: Shipping Biological Materials & Dry Ice
* Required for all staff shipping biological material (or transporting human/animal
specimens in their own vehicle)
Page 2 of 2