Single IRB Specialist
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Job Location:
Somerville, NJ - USA
Monthly Salary:
$ 62004 - 90750
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
In addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
The role is the face of MGBs IRB to work with external institutions PIs and IRBs to get reliance agreement information and local context information. Much of the role is making sure the correct documentation and reliance agreements are in place. The ideal candidate has previously Single IRB experience.
Job Summary
Responsible for reviewing and approving applications for participating sites that are relying on IRB oversight. This position ensures that all site-specific institutional requirements have been met prior to approval/activation of the research at each participating site. Also responsible for reviewing requests from research to rely on the review to external IRBs. This position involves regular interaction with others within the system including offices and ancillary committees involved in the Human Research Protection Program. Reports to Assistant Director sIRB Program.Essential Functions
-Acts as the primary liaison for investigators relying on external sIRBs and investigators at sites relying on the IRB for sIRB oversight in multi-site research.
-Conducts reviews of applications for relying sites overseen by the sIRB in compliance with all applicable federal state and local regulations as well as institutional policies and procedures and guidelines.
-Determines the eligibility to rely on external reviewing sIRBs based on institutional policies and standard operating procedures.
-Coordinates the review and negotiation of individual study reliance agreements with external sIRBs when needed; prepares individual investigator agreements for investigators who are employees/agents of institutions.
-Communicates policies and requirements to external sIRBs as applicable; reviews model consent form(s) for compliance with consent form requirements (such as payment for injury HIPAA).
-Participates in the development and implementation of educational workshops and activities for the research community.
-Works with the Assistant Director and others to identify and resolve problems and formulate short- and long-term goals and objectives.
-Interacts as needed with federal and state regulatory agencies
Qualifications
Education
- Bachelors Degree required (experience can be substituted in place of a degree)
- Masters Degree preferred
Licenses/Certifications
- IRB professional (CIP) within 2 years of hire 1-2 years preferred
Experience
- At least 5-7 years of experience in clinical research or regulatory affairs required
Knowledge Skills and Abilities
- Excellent communication interpersonal and organizational skills.
- Ability to work independently and as a team member.
- Working knowledge of clinical research protocols.
- Analytical skills and ability to resolve problems.
- Strong understanding of federal regulations such as the Common Rule HIPAA and other relevant research compliance standards.
- High degree of computer literacy.
Additional Job Details (if applicable)
Working Conditions
- This is a full-time remote role that can be done from most US states
- The Monday through Friday schedule is five 8-hour days with a preference for a start time no later than 8:30 AM EDT on weekdays
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$62004.80 - $90750.40/AnnualGrade
7EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham our competency framework defines what effective leadership looks like by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance make hiring decisions identify development needs mobilize employees across our system and establish a strong talent pipeline.
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Patients at Mass General have access to a vast network of physicians, nearly all of whom are Harvard Medical School faculty and many of whom are leaders within their fields.
