Single IRB Liaison Assistant Regulator Manager at Partner's Healthcare in Somerville, Massachusetts

Job Description:

Site: The General Hospital Corporation


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.



Job Summary
The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials.


Reporting to the Director of Quality Assurance, the Single IRB Liaison Assistant Regulatory Manager (sIRB ARM) will assist the Regulatory Manager(s) in liaising between the study teams and the Mass General Brigham Human Research Committee/ Institutional Review Board.



Qualifications


Relevant activities include, but are not limited to the following:

• Schedule and develop meeting agendas and minutes in collaboration with the study team, both remotely and in person, and lead meetings/calls as needed.


• Draft and submit sIRB applications, including amendments, protocol deviations, unanticipated problems, and adverse events.


• Upload and save documents to the internal shared drive, electronic data capture systems, and regulatory document systems, as applicable.


• Notify Project Management teams when cIRB submissions have been approved and documents have been uploaded.


• Provide the Project Management team with weekly updates on all s IRB studies.


• Assist with setting priorities and creating timelines for the sIRB team.


• Assist with the Reliance Agreement execution process.


• Assist with revising study documents, including informed consent forms, recruitment materials, and other study tools.


• Troubleshoot routine/non-routine problems and take measures to correct/handle issues.


• Incorporate data from existing information into spreadsheets/databases in an organized and presentable format.


• Keep current on federal, state, and local laws and regulations governing human-subject research through attendance at conferences, workshops, seminars, or lectures pertaining to human-subject protection.


• Takes on additional duties as assigned within the scope of the role.

SKILLS & COMPETENCIES REQUIRED:

• Demonstrated knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines is preferred but not required.


• Attention to detail and excellent organizational skills.


• Excellent verbal and written communication.


• Excellent computer skills and proficiency with Microsoft Office are required.


• Ability to work independently as well as a team player who can take direction.


• Ability to effectively and efficiently work within an extremely fast moving, deadline-driven environment, while balancing multiple tasks simultaneously.

EDUCATION:


Bachelor's Degree



EXPERIENCE:


At least one year of experience in research or a related field


Background/familiarity with biology or other scientific disciplines is preferred but not required.


WORKING CONDITIONS:


This position can be either hybrid or remote. Must have reliable internet access. On occasion and at the discretion of the Director of QA, the Assistant Regulatory Manager may be required to be onsite for meetings, sponsor audits or regulatory inspections. Advanced notice will be given.



Additional Job Details (if applicable)



Physical Requirements

• Standing Frequently (34-66%)


• Walking Frequently (34-66%)


• Sitting Occasionally (3-33%)


• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)


• Carrying Frequently (34-66%) 20lbs - 35lbs


• Pushing Occasionally (3-33%)


• Pulling Occasionally (3-33%)


• Climbing Rarely (Less than 2%)


• Balancing Frequently (34-66%)


• Stooping Occasionally (3-33%)


• Kneeling Occasionally (3-33%)


• Crouching Occasionally (3-33%)


• Crawling Rarely (Less than 2%)


• Reaching Frequently (34-66%)


• Gross Manipulation (Handling) Frequently (34-66%)


• Fine Manipulation (Fingering) Frequently (34-66%)


• Feeling Constantly (67-100%)


• Foot Use Rarely (Less than 2%)


• Vision - Far Constantly (67-100%)


• Vision - Near Constantly (67-100%)


• Talking Constantly (67-100%)


• Hearing Constantly (67-100%)

Remote Type


Hybrid



Work Location


399 Revolution Drive



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.



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. Apply Now