Expedited Specialist

Site: Mass General Brigham Incorporated

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.

Job Summary

The Expedited Specialist II will conduct reviews of submitted human subject research applications in accordance with federal requirements, Human Research Office (HRO) policies and procedures and accreditation standards. Under the direction of the Assistant Director, the Expedited Specialist will work with personnel in all areas of the submission and review process to ensure appropriate screening and review of research documents, and provide support to research staff on research submissions, training requirements, and updated processing procedures. The Expedited Specialist II independently understands and applies the federal and state regulations for human subjects research to studies submitted for category determination to ensure adherence to regulatory and ethical standards. The responsibilities of this position also include assisting the Assistant Director with educational initiatives (e.g., presentations to the research community, HRO staff), providing regulatory consults for the research community, contributions to and participation in IRB initiatives, process improvement, and HRO optimization goals.

The Expedited Specialist II is designated by the MGB Institutional Review Board (IRB) Chair to review, require modifications to, and approve research designated by the federal regulations as eligible for expedited review across all types of applications. The Expedited Specialist II is also responsible for determining when an activity meets the definition of human subject research under federal regulations, and determine when research is exempt under the federal regulations. The Expedited Specialist II works with others, as appropriate, on the development of or updates to MGB policies and procedures. This position involves regular interaction with others within the MGB system with responsibility for some aspect of the human research protection program.

Duties and Responsibilities

1. Act as a member of the MGB IRB and expedited reviewer as designated by the MGB IRB Chair

2. Work independently to review research activity submitted to the MGB IRB to

a. determine research is not human subjects research or a clinical investigation subject to IRB review;

b. determine if research meets exemption criteria

c. approve non-exempt minimal risk research using the expedited review procedure

d. approve minor changes in approved research

e. conduct continuing review of approved minimal risk research

f. review other events.

3. Review human research protocol submissions according to standard operating procedures to ensure that human subject research overseen by the MGB IRB complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines.

4. Compose correspondence to investigators articulating modifications required in the research to secure IRB approval and any questions, concerns, or clarifications that need to be addressed before IRB approval can be considered.

5. Identify requirement(s) for review by the ancillary committees, or communication or coordination with other departments, groups, or individuals within the institution that share responsibility for human subject protection.

6. Work with the research community in a collaborative manner to provide guidance and consultation to investigators and clinical research personnel about the MGB IRB policies and procedures and changes needed to secure IRB approval of submitted protocols.

7. Adhere to turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes.

8. Attend IRB meetings and act as a voting member as needed

9. With Assistant Director and others, develop and implement new policies, procedures, and educational information as needed.

10. Work with Assistant Director and others to develop and present educational initiatives for the research community on applicable HRO policies, procedures, federal and state regulations, and ethical principles.

11. Participate in the development and implementation of educational workshops and activities for the research community.

12. Provide one-on-one ethical and regulatory consultation to Principal Investigators and research teams regarding submission of IRB applications and conduct of research.

13. Participate in regional and national conferences and educational events

14. Assumes additional responsibilities as assigned by the Assistant Director.

Qualifications

Education

• Bachelor's degree required; Master's degree in medically-related area preferred (Nurse Practitioner, Physician's Assistant)

Licenses and Certifications

• Certified IRB professional (CIP) credential in good standing (or must pass certification exam within first 90 days of employment)

Work Experience

• At least 1-2 years of knowledge of federal, state, and local laws and regulations governing human subjects research required
• Minimum of 3 years of relevant experience in IRB, clinical research, and/or regulatory affairs

Knowledge, Skills, and Abilities

• Excellent oral and written communication skills.
• Excellent organizational skills with the ability to prioritize work and adhere to timelines.
• Ability to assess institutional and federal criteria and apply it to a variety of situations, and make decisions based on specified criteria.
• Excellent interpersonal skills to effectively communicate with cross-functional teams, including staff at all levels of the organization and both scientific/medical and non-scientific/medical personnel.
• Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization.
• Ability to effectively conduct meetings, both formal and informal, and to lead and facilitate large working sessions with all levels of staff.
• Self-motivated, independent, and possesses the ability to learn quickly.

Additional Job Details (if applicable)

Working Conditions

• This is a full-time, remote role that can be done from most US states
• This role has a Monday through Friday, 8:30 AM to 5 PM ET schedule

Remote Type

Remote

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. 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.

EEO Statement:

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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.