Regulatory is the day-to-day management of policy and support provided to ensure that clinical trials are appropriately evaluated, investigated and submitted.

GRADY

Office of Research Administration 

Mission

The Office of Research Administration partners with Grady’s Research Oversight Committee and Research personnel to protect the rights, welfare, and well-being of human subjects involved in research within Grady Health System.

Services

The Office of Research Administration has the responsibility of adhering to and abiding by all regulatory requirements including those from the Office of Human Research Protections (OHRP), the Institutional Review Boards of the affiliated institutions (IRBs) and The Joint Commission.

The Office of Research Administration provides Oversight and support for the initiation and execution of research within Grady Health System.  ORA consists of Administrative and Financial units.

The Office of Research Administration has the responsibility of maintenance for various systems required for providing management reports.  Those services include:

  1. Review all research protocols and required documents in order to support Grady’s Research Oversight Committee in determining risks and benefits to patients.
  1. Serve as liaisons for but not limited to Grady’s Research Oversight Committee, Compliance, Information Security, Information Technology, Legal and On-Boarding/Training departments

Additionally, we share a strong affiliation with Grady’s Office of Grants Administration.


The following forms should be used to conduct a study at Grady. 

Forms 

ORA FORMS

Conduct of Research Forms & Tip Sheets


 

GRADY ORA STAFF 

Chadrick Anderson, Director 
Office of Research Administration and Grady Clinical Research Center

Shirley Marshall, Research Administration Specialist 
Office of Research Administration

Yvette Benjamin, Sr. Research Financial Analysist 
Office of Research Administration-Finance

Grady Hospital 
80 Jesse Hill Jr. Drive, SE, 
Room #3A020 
Atlanta, Georgia 30303

ORA Administrative Email:  .

ORA Finance Email:  .

Roles and Responsibilities

  • Obtaining a copy all investigators and coordinators licenses, human subjects training, HIPAA, picture identification and NIH biosketches
  • Maintaining all regulatory documents for each clinical trial. A completed CRC application is needed for all trials utilizing the CRC or its resources.
  • Maintaining a record of Adverse Events, Serious Adverse Events and other safety information as required by institutional, sponsor, NIH or federal guidelines
  • Dispersing a variety of information associated with clinical protocols and the daily operations of clinical trials
  • Serving as a liaison to MSM Institutional Review Board (IRB) and Grady Research Oversight Committee (ROC) as well as assisting in the preparation of materials to be submitted

Click here for link to register in IRB Net

Contact:

Carla Holloway 
Regulatory   
Morehouse School of Medicine  
Clinical Research Center  
720 Westview Drive, S.W.  
Atlanta, Georgia 30310  
Phone: (404) 752-8452

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