Training for Clinical Research Staff

The Office for Clinical Research (OCR) offers several training programs for clinical research staff.  However, training is required for those who are conducting or coordinating FDA-regulated clinical trials. For more information, please read the Clinical Research Education Requirements and Revised Training Letter.  Please verify with your manager or supervisor on your training needs.

Click on the name of the role to review content information.

Investigators (PI, Co-I, Sub-I)

Investigators include PIs, Co-Is, Sub-Is, and residents/fellows/nurses functioning in the role of an investigator.

Courses Description CMEs/CEUs? Renewal?
CITI Biomedical Focus An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position. Credits are provided by CITI. Every 3 years.
CITI Good Clinical Practice (GCP) and ICH In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position. Credits are provided by CITI. Every 3 years.
Conflict of Interest
(COI)
An on-line course facilitated in eCOI and offered by the Office of Conflict of Interest (COI) for faculty and staff to certify that they have received information about Emory's policies and the federal regulations on Objectivity in Research.
Credits are provided by CITI. Every 4 years.
Environmental Health and Safety 
(EHSO)
EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials. No As needed due to new regulations.
HIPAA In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.
No As needed due to new regulations.
For more information about the courses and registration, visit the Courses page.

Mid-Levels: Physician Assistant (PA) or Nurse Practitioner (NP)

Mid-Levels include PAs or NPs.  Both roles may function in the following delegated roles:

a)   Performing duties as an investigator, including those that grade adverse events.
b)   Performing duties as a study coordinator (i.e. day-to-day management of the protocol, consenting subjects).
c)   Performing clinical functions as a licensed PA or NP.
d)   In a discovery phase, only observing or shadowing an investigator.

Courses Description CMEs/CEUs? Renewal?

CITI Biomedical Focus

An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to mid-levels in groups a, b, c, and d.

Credits are provided by CITI. Every 3 years.

CITI Good Clinical Practice (GCP) and ICH

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to mid-levels in groups a and b only.

Credits are provided by CITI. Every 3 years.

CITI Clinical Research Coordinator

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to mid-levels in group b only if 5 years or more of clinical research experience.

Credits are provided by CITI. No

2-day Classroom Introduction to Clinical Research

A course offered in a classroom environment for clinical research coordinators, research nurses, fellows, and residents new to Emory or clinical research. The course is designed to provide a basic framework of the roles and responsibilities to equip clinical research coordinators, research nurses, fellows, and residents with the tools to be successful in their job roles at Emory.

Training applies to mid-levels in group b only if less than 5 years of clinical research experience)

14 AMA PRA Category 1 Credits™ are issued as continuing credits when requested. No

Conflict of Interest
(COI)

An on-line course facilitated in eCOI and offered by the Office of Conflict of Interest (COI) for faculty and staff to certify that they have received information about Emory's policies and the federal regulations on Objectivity in Research.

Training applies to mid-levels in groups a, b, c, and d.

No Every 4 years.

Environmental Health and Safety
(EHSO)

EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials.

Training applies to mid-levels in groups a, b, and c.

No As needed due to new regulations.

HIPAA

In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.

Training applies to mid-levels in groups a, b, c, and d.

No As needed due to new regulations.
For more information about the courses and registration, visit the Courses page.

Residents and Fellows

Residents (medical school graduate undergoing on-the-job training) or Fellows (residency graduate undergoing continued specialty training) may function in the following delegated roles:

a)    Performing duties as an investigator, including those that grade adverse events.
b)    Performing duties as a study coordinator (i.e. day-to-day management of the protocol, consenting subjects).
c)    Performing clinical functions as a physician under the supervision of a licensed physician.
d)    In a discovery phase, only observing or shadowing an investigator.

Courses Description CMEs/CEUs? Renewal?

AHA Basic Life Support
(CPR)

 

A classroom course offered by the Office for Clinical Research to teach Emory University Clinical Research Staff on the skills of CPR for victims of all ages, including the use of an automated external defibrillator and the relief of choking.

The course is also required for Emory University clinical research staff who need Emory Healthcare credentialing and will be working in an Emory Healthcare facility.

Training applies to residents and fellows in groups a, b, and c.

No Every 2 years.

CITI Biomedical Focus

An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to residents and fellows in groups a, b, c, and d.

Credits are provided by CITI. Every 3 years.

CITI Good Clinical Practice (GCP) and ICH

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to residents and fellows in groups a and b only.

Credits are provided by CITI. Every 3 years.

CITI Clinical Research Coordinator

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to residents and fellows in group b only if 5 years or more of clinical research experience.

Credits are provided by CITI. No

2-day Classroom Introduction to Clinical Research

A course offered in a classroom environment for clinical research coordinators, research nurses, fellows, and residents new to Emory or clinical research. The course is designed to provide a basic framework of the roles and responsibilities to equip clinical research coordinators, research nurses, fellows, and residents with the tools to be successful in their job roles at Emory.

Training applies to residents and fellows in group b only if less than 5 years of clinical research experience).

14 AMA PRA Category 1 Credits™ are issued as continuing credits when requested. No

Conflict of Interest
(COI)

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to residents and fellows in groups a, b, and c.

No Every 4 years.

Emory Research Management System
(ERMS)

A classroom course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules.

The course is required if you will be consenting subjects and tracking their visits.

Training applies to residents and fellows in group b only.

No No, but a refresher is highly recommended due to process changes.

Environmental Health and Safety
(EHSO)

EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials.

Training applies to residents and fellows in groups a, b, and c.

No As needed due to new regulations.

HIPAA

In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.

Training applies to residents and fellows in groups a, b, c, and d.

No As needed due to new regulations.

For more information about the courses and registration, visit the Courses page.

Medical Students

Medical students (student in a graduate-level medical program) may function in the following delegated roles:

a)    Performing duties as a study coordinator (i.e. day-to-day management of the protocol, consenting subjects).
b)    Performing clinical functions as a physician under the supervision of a licensed physician.
c)    In a discovery phase, only observing or shadowing an investigator.

Courses Description CMEs/CEUs? Renewal?

CITI Biomedical Focus

An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to medical students in groups a, b, and c.

Credits are provided by CITI. Every 3 years.

CITI Good Clinical Practice (GCP) and ICH

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to medical students in group a only.

Credits are provided by CITI. Every 3 years.

CITI Clinical Research Coordinator

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to medical students in group a only if 5 years or more of clinical research experience.

Credits are provided by CITI. Every 3 years.

2-day Classroom Introduction to Clinical Research

A course offered in a classroom environment for clinical research coordinators, research nurses, fellows, and residents new to Emory or clinical research. The course is designed to provide a basic framework of the roles and responsibilities to equip clinical research coordinators, research nurses, fellows, and residents with the tools to be successful in their job roles at Emory.

Training applies to medical students in group a only if less than 5 years of clinical research experience)

14 AMA PRA Category 1 Credits™ are issued as continuing credits when requested. No

Conflict of Interest (COI)

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to medical students in groups a and b.

No Every 4 years.

Emory Research Management System (ERMS)

A classroom course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules.

The course is required if you will be consenting subjects and tracking their visits.

Training applies to medical students in group a.

No No, but a refresher is highly recommended due to process changes.

Environmental Health and Safety (EHSO)

 

EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials.

Training applies to medical students in groups a, b, and c.

No As needed due to new regulations.

HIPAA

In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.

Training applies to medical students in groups a, b, and c.

No As needed due to new regulations.

For more information about the courses and registration, visit the Courses page.

Research Nurses

Research Nurses may be responsible for organizing, overseeing, and assisting in the clinical trial. Additionally, they may administer medications or perform other treatment procedures, and function in the following delegated roles:

a)    Performing duties as an investigator, including those that grade adverse events.
b)    Performing duties as a study coordinator (i.e. day-to-day management of the protocol, consenting subjects).
c)    Performing clinical functions as a licensed Registered Nurse (RN).
d)    In a discovery phase, only observing or shadowing an investigator.


Courses Description CMEs/CEUs? Renewal?

AHA Basic Life Support (CPR)

 

A classroom course offered by the Office for Clinical Research to teach Emory University Clinical Research Staff on the skills of CPR for victims of all ages, including the use of an automated external defibrillator and the relief of choking.

The course is also required for Emory University clinical research staff who need Emory Healthcare credentialing.

Training applies to research nurses in groups a, b, and c.

No Every 2 years.

CITI Biomedical Focus

An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to research nurses in groups a, b, c, and d.

Credits are provided by CITI. Every 3 years.

CITI Good Clinical Practice (GCP) and ICH

(applies to groups a and b only)

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to research nurses in groups a and b only.

Credits are provided by CITI. Every 3 years.

CITI Clinical Research Coordinator

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to research nurses in group b only if 5 years or more of clinical research experience.

Credits are provided by CITI. No

2-day Classroom Introduction to Clinical Research

A course offered in a classroom environment for clinical research coordinators, research nurses, fellows, and residents new to Emory or clinical research. The course is designed to provide a basic framework of the roles and responsibilities to equip clinical research coordinators, research nurses, fellows, and residents with the tools to be successful in their job roles at Emory.

Training applies to research nurses in group b only if less than 5 years of clinical research experience.

14 AMA PRA Category 1 Credits™ are issued as continuing credits when requested. No

Conflict of Interest
(COI)

A on-line course facilitated in eCOI and offered by the Office of Conflict of Interest (COI) for faculty and staff to certify that they have received information about Emory's policies and the federal regulations on Objectivity in Research.

Training applies to research nurses in groups a, b, c, and d.

No Every 4 years.

Emory Research Management System (ERMS)

A classroom course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules.

The course is required if you will be consenting subjects and tracking their visits.

Training applies to research nurses in group b only.

No No, but a refresher is highly recommended due to process changes.

Environmental Health and Safety
(EHSO)

 

EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials.

Training applies to research nurses in groups a, b, and c.

No As needed due to new regulations.

HIPAA

In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.

Training applies to research nurses in groups a, b, c, and d.

No

As needed due to new regulations.

For more information about the courses and registration, visit the Courses page.

Study Coordinator or Clinical Research Coordinators

Study Coordinators supports, facilitates, and coordinates the day-to-day management of the study activities and plays a critical role in the conduct of the study. They may function in the following delegated roles:

a)    Performing duties as a study coordinator (i.e. day-to-day management of the protocol, consenting subjects).
b)    In a discovery phase, only observing or shadowing an investigator.


Courses Description CMEs/CEUs? Renewal?

AHA Basic Life Support (CPR)

 

A classroom course offered by the Office for Clinical Research to teach Emory University Clinical Research Staff on the skills of CPR for victims of all ages, including the use of an automated external defibrillator and the relief of choking.

The course is also required for Emory University clinical research staff who need Emory Healthcare credentialing.

Training applies to coordinators in group a only.

No Every 2 years.

CITI Biomedical Focus

An on-line course facilitated in CITI and offered by the University of Miami in collaboration with Emory University Institutional Review Board (IRB).  The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to coordinators in groups a and b.

Credits are provided by CITI. Every 3 years.

CITI Good Clinical Practice (GCP) and ICH

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to coordinators in groups a and b.

Credits are provided by CITI. Every 3 years.

CITI Clinical Research Coordinator

In addition to Biomedical Focus CITI course, this on-line course is offered by University of Miami in collaboration with the Office for Clinical Research (OCR). The course is web-based and required prior to submitting research protocols for review and approval for all Key Personnel listed on the Emory IRB submission, regardless of their position.

Training applies to coordinators in group a only if 5 years or more of clinical research experience.

Credits are provided by CITI. No

2-day Classroom Introduction to Clinical Research

A course offered in a classroom environment for clinical research coordinators, research nurses, fellows, and residents new to Emory or clinical research. The course is designed to provide a basic framework of the roles and responsibilities to equip clinical research coordinators, research nurses, fellows, and residents with the tools to be successful in their job roles at Emory.

Training applies to coordinators in group a only if less than 5 years of clinical research experience.

14 AMA PRA Category 1 Credits™ are issued as continuing credits when requested. No

Conflict of Interest (COI)

A on-line course facilitated in eCOI and offered by the Office of Conflict of Interest (COI) for faculty and staff to certify that they have received information about Emory's policies and the federal regulations on Objectivity in Research.

Training applies to coordinators in groups a and b.

No Every 4 years.

Emory Research Management System (ERMS)

A classroom course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules.

The course is required if you will be consenting subjects and tracking their visits.

Training applies to coordinators in group a only.

No No, but a refresher is highly recommended due to process changes.

Environmental Health and Safety
(EHSO)

 

EHSO offers several courses to provide guidance for the use, storage and disposal of the following materials used in research, clinical, academic, and operational activities: biological toxins, infectious agents, recombinant DNA agents, chemical, and radioactive materials.

Training applies to coordinators in groups a and b.

No As needed due to new regulations.

HIPAA

In order to meet HIPAA related training requirements (including those related to the health and safety compliance question sets) individuals can complete their HIPAA trainings through the Emory Learning Management System (ELMS) provided by the Office of Compliance.  The HIPAA trainings are: 1) HIPAA in a Hurry - Privacy rule; 2) HIPAA and Research; and 3) HIPAA Security.

Training applies to research nurses in groups a and b.

No As needed due to new regulations.

For more information about the courses and registration, visit the Courses page.

Other Staff or Supporting Roles

There are several job roles in the list below that support the study team in conducting or coordinating the clinical study or trial. If your job duties consist of consenting subjects or managing the protocol plan, you may be required to complete one or more of the required courses. For assistance, please contact the Office for Clinical Research at OCR@emory.edu for a member of the Education and Outreach team to help guide you with your training requirements.

Examples of other staff or supporting roles:

  • Research Interviewer  
  • Phlebotomist 
  • Research Assistant
  • Research Associate
  • Physical Therapist
  • Administrative Assistant
  • Nurses
  • Pharmacist
  • Laboratory technician
  • Statistician
  • Business Manager
  • Regulatory staff
  • Data coordinator
  • Research Administrators
  • Infusion technicians