IRB Compliance Administrator

IMDiversity; Cambridge (MA); Hybrid; USD 77,500 - 105,100; Full time

Benefits offered by this job

Hybrid work model

Competitive pay

Job summary

IMDiversity in Cambridge, MA, is seeking an IRB Compliance Administrator within the Office of the Vice President for Research to oversee ethical and regulatory reviews for human subjects research.

The role requires a Bachelor's degree, at least three years of related experience, strong analytical and written/oral communication skills, and familiarity with FDA regulations. It is a full-time hybrid position with a pay range of $77,500–$105,100.

Qualifications

• Bachelor's degree in related field required.
• Minimum of three years of human subjects research experience.
• Experience with FDA-regulated device research and related regulations.
• Excellent analytical, organizational, and written and oral communication skills.
• Experience conducting human subjects research in academic settings.
• Must obtain CIP certification within one year if not already certified.

Responsibilities

• Conduct regulatory reviews of human subject research protocols and identify risks to participants.
• Review expedited studies and prepare high-level protocol summaries.
• Advise investigators on regulatory requirements and documentation.
• Assist with committee minutes, communications, and educational materials.

Skills

Analytical thinking

Organizational skills

Written and oral communication

Attention to detail

Multitasking & prioritization

Collaboration with stakeholders

Regulatory language familiarity

Education

Bachelor's degree in related field

CIP certification (preferred)

Job description

IRB Compliance Administrator

Job Number: 25895

Functional Area: Administration

Department: VP for Research

School Area: VP Research

Pay Range Minimum: $77,500

Pay Range Maximum: $105,100

Employment Type: Full-time (Hybrid)

Employment Category: Exempt

Visa Sponsorship Available: No

Schedule:

Pay Grade: 8

Posting Description

• INSTITUTIONAL REVIEW BOARD (IRB) COMPLIANCE ADMINISTRATOR, Office of the Vice President for Research, to conduct ethical and compliance reviews to ensure compliance with applicable laws and regulations for the use of human subjects in research.


• Will serve as a point of contact (POC) and compliance reviewer of human subject research protocols; conduct research protocol reviews to identify regulatory and other issues and identify potential risks to research participants; independently reviews and approves studies eligible for expedited review in accordance with the applicable expedited review categories; assists with taking Committee minutes, correspond with and advise investigators, articulating modifications to study documentation; write high-level protocol summaries, coordinate ancillary reviews, and advise colleagues/investigators on navigating the regulatory landscape and applicability of regulations; assist with developing educational materials and conduct workshops/presentations; assist with COUHES Connect; maintain knowledge of federal/state/local regulations; and support other functions as needed.

Job Requirements

• REQUIRED: Bachelor's degree in related field; a minimum of three years of human subjects research related experience; experience with FDA regulated device research, working knowledge of state and federal regulations pertaining to human subject research; excellent analytical, organizational, and written and oral communication skills; understanding of research procedures’ terminology, clinical trials, and research data management; experience conducting and managing human subject research in an academic research environment; attention to detail; discretion and good judgment with confidential information; and ability to multitask and prioritize in a fast-paced environment and collaborate with faculty, staff, and institutional representatives.


• If not already Certified IRB Professional (CIP) certified, must obtain CIP certification within one year of meeting the eligibility requirements for the CIP certification exam.


• PREFERRED: Three years of experience working at an IRB; experience conducting expedited and primary reviews for an IRB; CIP certification; previous experience working at an AAHRPP-Accredited IRB/HRPP; experience serving as an IRB board member and administrative record keeping; Experience conducting expedited and primary reviews for an IRB; experience reviewing DOD, NIH, and NSF supported/regulated research; and a background in science and engineering.

This position will be hybrid.