Welcome page Returning Candidate? Log back in! RESEARCH ASSOCIATE Vacancy ID 11625 Pos. Category Research Job Location : Street 707 N Broadway # of Hours 40.00 Job Locations US-MD-Baltimore Pos. Type Regular Full Time Department : Name Muscle Center Overview

The Research Associate will provide expertise, oversight, and implementation across two functional areas of the Institute. The primary area of support is within Kennedy Krieger Institute’s Department of Research Administration as the designated institutional lead administrator to manage the Institute’s process for relying on review of Institutional Review Boards (IRBs) other than the Johns Hopkins Medicine IRB. The secondary area of support will be within Kennedy Krieger Institute’s Center for Genetic Muscle Disorders as the primary regulatory affairs administrator providing guidance on a day-to-day basis with respect to the conduct of their human research programs.

Responsibilities

1. Oversee and execute the Institute-level initial and ongoing administrative and regulatory review and approval process within Research Administration’s Office of Human Research Administration for all human subjects research studies that will rely on Institutional Review Boards (IRB) other than the Johns Hopkins Medicine IRB.

2. Provide guidance, education, and support to all departments and divisions at Kennedy Krieger Institute regarding the process and requirements for submitting human subjects research studies to an IRB other than the Johns Hopkins Medicine IRB.

3. Serve as an institutional expert regarding Kennedy Krieger Institute policies and practices for the conduct of human subjects research.

4. Maintain awareness of changes in state and national regulations impacting the conduct of research involving human subjects and provide advice to research leadership and others at the Institute.

5. Assist in the development and revision of relevant Center for Genetic Muscle Disorders policies, guidance, and training materials related to IRB submissions, including Single-IRB submissions.

6. Oversee regulatory and IRB submissions for the Center for Genetic Muscle Disorders and ensure successful hand-off to assigned primary study team coordinator as start-up phase ends.

7. Liaise with industry sponsors, external IRBs, relevant personnel at the Johns Hopkins University School of Medicine, and other external universities and partners.

8. Support research collaborators with data collection and analysis for scientific presentations and manuscript preparations.

Qualifications

QUALIFICATIONS:

Certified in Healthcare Research Compliance (CHRC), Certified IRB Professional (CIP), or related certification preferred.

 

EDUCATION:

· Master’s degree in research, legal, scientific, or related technical field of study required.

· Doctoral degree preferred.

 

EXPERIENCE:

· Minimum 8 years of experience in research regulatory affairs or human subjects’ research oversight at an active academic health center, university, or government agency required.

· Demonstrated experience in overseeing the approval, implementation, and conduct of human subjects research protocols from planning through completion and reporting, and in ensuring that the study is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, applicable institutional and IRB policies and procedures, and the research protocol.

· Prior experience with the external reliance (Single IRB) process from start-up to implementation.

Minimum pay range USD $72,000.00/Yr. Maximum pay range USD $115,000.00/Yr. Options Apply for this job onlineApplyShareRefer a friendRefer a friend Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed JOIN OUR TALENT COMMUNITY Not ready to apply? Connect with us Application FAQs

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