IRB Coordinator - Office of Research and Economic Development

Florida International University is a top public university that drives real talent and innovation in Miami and globally. Very high research (R1) activity and high social mobility come together at FIU to uplift and accelerate learner success in a global city by focusing in the areas of environment, health, innovation, and justice. Today, FIU has two campuses and multiple centers. FIU serves a diverse student body of more than 56,000 and 290,000 Panther alumni. U.S. News and World Report places dozens of FIU programs among the best in the nation, including international business at No. 2. Washington Monthly Magazine ranks FIU among the top 20 public universities contributing to the public good.

Coordinates the daily activities of the Institutional Review Board (IRB) process for human subject research. Reviews and analyzes protocol applications and participates in conducting ORI compliance education/outreach activities for faculty, staff and students.

• Coordinates the activities of the Social and Behavioral Institutional Review Board (SB-IRB) and the Health Sciences Institutional Review Board (HS-IRB)
• Assists in the development, implementation and maintenance of SOPs, educational materials, and associated forms and policies.
• Assists with protocol submissions requiring WCG IRB approval, single IRB review, and IRB reliance requests.
• Reviews new protocol submissions, continuing reviews, amendments, and informed consent forms to ensure accordance with OHRP/FDA regulations.
• Assists with post approval monitoring of protocols.
• Coordinates the IRB review workflow and assigns protocols to board members for review.
• Provides investigators with guidance on the IRB submission process and contacts investigators for additional information as needed.
• Updates IRB committee members on new federal regulation developments and the appropriateness of review procedures.
• Records meeting minutes of convened committee meetings.
• Updates and maintains protocols through the online IRB protocol submission system.
• Participates in conducting ORI compliance education/outreach activities for IRB committee members, faculty, staff and students.
• Processes and/or drafts approval letters for initial, amendment, renewal and event report form submissions.
  

Bachelor's degree and two (2) years of relevant experience.

• IRB, auditing, managing clinical trials and/or QA/QI experience.
• Experience in a clinical research environment.,
• Working knowledge of OHRP and FDA regulations.

Administrative

$55,000 - $60,000

Begin time: 8:30 AM
End time: 5:00 PM

Criminal Background Check

Prospective Employee

If you have not created a registered account, you will be asked to create a username and password for use of the system. It is recommended that you provide an active/valid e-mail account as that will be the main source of communication regarding your status within the process. In this account, you are able to track your applicant status in "My Applications".

To be considered eligible for the position as an internal candidate, departmental staff must meet minimum requirements of the position and be in good performance standing.

Before you begin the process, we recommend that you are prepared to attach electronic copies of your resume, cover letter or any other documents within the application process. It is recommended that you combine your cover letter and resume/curriculum vitae into one attachment. Attached documents should be in Microsoft Word or PDF format. All applicants are required to complete the online application including work history and educational details (if applicable), even when attaching a resume.

*This posting will close at 12:00 am of the close date.

Current Employee

As a current employee, you must log into Employee Self Service (ESS) to apply for this and any other internal career opportunity of interest. In this account, you are able to track your applicant status in "My Applications".

To be considered eligible for the position as an internal candidate, departmental staff must meet minimum requirements of the position and be in good performance standing.

Before you begin the process, we recommend that you are prepared to attach electronic copies of your resume/ curriculum vitae, cover letter or any other documents within the application process. It is recommended that you combine your cover letter and resume into one attachment. Attached documents should be in Microsoft Word or PDF format.

*This posting will close at 12:00 am of the close date.

Clery Notice

In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act, the University Police department at Florida International University provides information on crimes statistics, crime prevention, law enforcement, crime reporting, and other related issues for the past three (3) calendar years. The FIU Annual Security report is available online at: https://police.fiu.edu/download/annual-security-fire-safety-report/.

To obtain a paper copy of the report, please visit the FIU Police Department located at 885 SW 109th Avenue, Miami, FL, 33199 (PG5 Market Station).

Pay Transparency

Florida International University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

FIU is a member of the State University System of Florida and an Equal Opportunity, Equal Access, Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.