Rsch Regulatory Analyst II

Apply now Job no: 531769
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration, Legal/Audit Services/Compliance
Department:11210000 - RE-IRB-01 HEALTH CENTER

Classification Title:

Research Regulatory Analyst II

Job Description:

Non-Full Board Related Duties:
- Accurately generate correspondence.This includes ‘needs reply’, ‘approved with contingencies’, suspensions, and other  approval letters.
- Acts as Liaison between reviewers and principal investigators. Maintaining verbal and written communication with Principal Investigators regarding the status of pending protocols and review
- Evaluates IRB submissions.
- Office board member/contingency approver, approve contingencies in accordance with office guidelines.

Full Board Meeting Functions Include:
- During Full Board meetings responsible for taking meeting minutes. Meeting Minutes must meet Federal regulatory/AAHRPP requirements which are built into the template.
- Based on reviewer notes/minutes, accurately compose and generate letters to the principal investors that report the results of the IRB Full Board review and instruct them when changes are required.
- Work with the IRB Chair to trouble shoot issues and note completion after the meeting.
- Prepare past Full Board finalized minutes for the Board approval.
- Coordinate virtual Full Board meetings including documentation of outcomes.

Board Meeting preparation functions include:
-Prepare IRB-01 Full Board meeting agendas.
- Evaluate research proposal content relative to the appropriate format, adequate completion, and correct language in order to be distributed to the Committee or the Chair for review.  This includes processing submissions electronically in myIRB 
-Analyze and evaluate proposals to ensure that proposals meet agency, federal, state, and university guidelines in preparation for Committee review.
-Review agenda items, board member attendance and prepare template language for minutes.

Other duties as assigned

Expected Salary:

$45,600-$55,000

Minimum Requirements:

Bachelor’s degree in an appropriate area and two years of experience in appropriate area; or an equivalent combination of education and experience.

Preferred Qualifications:

Bachelor’s Degree in Basic Sciences and/or Health Care and two years of research/regulatory experience.
Foundational understanding of Federal, state, and local regulations and rules.
Excellent written and oral communication skills.
Foundational understanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subjects.
Qualities:
Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, coordinators, and office staff.
Ability to act as liaison and to use negotiation skills to resolve conflicts with investigators regarding their protocols.
Skills/Abilities:
Excellent oral and written communication skills, ability to work independently, and detail oriented.

Proficiency with the Microsoft Office suite, Zoom, myIRB.

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter, resume and a list of three professional references.

A criminal background check is required.

This position is located on the University of Florida main campus in Gainesville, FL.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: No. 

 

Advertised: Eastern Daylight Time
Applications close: Eastern Daylight Time

Back to search results Apply nowRefer a friend


Send me jobs like these

We will email you new jobs that match this search.