sIRB Regulatory Manager II

5 days ago

Somerville, United States Massachusetts General Hospital Full time
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 Regulatory Manager II/ Single IRB Liaison will be a key liaison between investigators, study teams, and the MGB's Human Research Committee/ Institutional Review Board.

PRINCIPAL DUTIES AND RESPONSIBILITIES

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

  • Act as the key liaison between the sIRB, investigators, relying investigational sites, and the Project Management Team.
  • Oversee and manage the sIRB submission process according to institutional policies and procedures, applicable federal regulations, and guidelines.
  • Review related human research protocols and consent forms for completeness and accuracy and adherence to institutional policies and procedures, applicable federal regulations, and guidelines governing the protection of human subjects in research.
  • Review consent forms to ensure that they contain all the basic elements for informed consent, as required by federal regulation, and work directly with study teams with editing/rewriting for readability at an 8th-grade reading level using principles of "plain language."
  • Identify requirements for ancillary committee reviews, and other departments, groups, or individuals within each site that share responsibility for human subject protection.


• Perform periodic audits of sIRB-related documentation in project Trial Master Files to ensure accuracy and completeness.

  • At the discretion of the Director of QA, responsible for HR processes for the sIRB Team such as interviewing, performance management and implementation of corrective actions.
  • 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.
  • Act as a resource for the study teams regarding federal, state, and local laws and regulations governing human-subject research.
  • Answer sIRB-related questions, resolve problems, and ensure timely and accurate sIRB submissions and approvals to ensure adherence to study timelines.
  • Act as a liaison with MGH Legal Counsel, the sIRB, and investigational sites to coordinate the finalization and execution of sIRB Reliance Agreements.
  • Train and mentor sIRB Liaison Team.
  • Take on additional tasks and responsibilities, as requested.


SKILLS & COMPETENCIES REQUIRED:

  • A solid understanding of clinical research methodology, FDA and OHRP regulations as well as ICH GCP is required.
  • Excellent leadership, presentation, and writing skills.
  • A solid understanding of clinical research methodology and regulations.
  • Ability to make independent effective decisions.
  • Ability to identify issues across studies and propose solutions.
  • The ability to develop and manage positive relationships with sponsor representatives (academic and industry-based), the sIRB, study team members, and other vendors.
  • Ability to lead and mentor cross-functional teams.
  • Experience writing and submitting IRB protocols and knowledge of regulatory processes and regulations is required.
  • Excellent computer skills working with Microsoft Office, and prior experience with the Insight electronic IRB submission platform is preferred.
  • Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
  • The ability to manage multiple studies and provide training, direct supervision, and/or appropriate mentoring to project manager(s), assistant project manager(s), and/or staff assistants.


EDUCATION:

Bachelor's Degree

EXPERIENCE:

Required:

  • A bachelor's degree is required.
  • Minimum of five (5) years of experience working in project management related to clinical research, academic research, or a similar environment is required.


Preferred:

  • Background/familiarity with biology or other scientific discipline is preferred, but not required.
  • Experience managing both academically-led and industry-led clinical trials is preferred, but not required.
  • Working for a study Sponsor, CRO, or commercial IRB is preferred, but not required.


SUPERVISORY RESPONSIBILITY

Indirect: Responsible for interviewing, hiring, and training of new staff as well as mentoring and/or direct supervision of 1 top 4 staff members.

WORKING CONDITIONS:

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

Massachusetts General Hospital 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.

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