Clinical Research Regulatory Manager/ Central IRB Liaison
Company: Massachusetts General Physicians' Organization
Posted on: May 12, 2022
minutes of inactivity. Job Description - Clinical Research
Regulatory Manager/ Central IRB Liaison (3191373) Job Description
Clinical Research Regulatory Manager/ Central IRB Liaison - (
3191373 ) Description The Neurological Clinical Research Institute
(NCRI), at the Massachusetts General Hospital (MGH) is a premier
Academic Clinical Research Organization (CRO) managing clinical
trials in neurological disorders. The NCRI employs physician
clinical researchers, research nurses, project managers, data
managers, SAS programmers, systems analysts, grants managers and
administrative assistants dedicated to planning and implementing
clinical trials. Reporting to a senior member of the PM team, the
Regulatory Manager/ Central IRB Liaison will act as a key liaison
between investigators, study teams and the Partner's Human Research
Committee/ Institutional Review Board. They will also be
responsible for providing guidance/assistance to various study
teams related to regulatory agency submissions, collection of
regulatory documents and maintenance of a Trial Master File (TMF).
PRINCIPAL DUTIES AND RESPONSIBILITIES: Primary Responsibility for
the following on assigned studies:
- Act as the key liaison between the investigators, relying
sites, the CIRB/PHRC, and Study Teams regarding all aspects of the
CIRB including the submission process, adherence to Standard
Operating Procedures (SOPs,) CIRB/PHRC policies and procedures and
all applicable federal regulations and guidelines.
- Review related human research protocols and consent forms for
completeness and accuracy as well as adherence to all applicable
federal/state regulations and institutional policies and guidelines
governing protection of human subjects in research.
- Review consent forms to ensure that they contain all the basic
required elements for informed consent, as required by federal
regulation, and work directly with CSS with editing/rewriting for
readability at an 8 th grade reading level using principles of
- Identify requirements for ancillary committee reviews, and
other departments, groups, or individuals within each site that
share responsibility for human subject protection.
- Attend meetings of the convened CIRB/PHRC as needed.
- Provide guidance to study teams on the process for collecting,
reviewing and approving site regulatory documentation
- Provide guidance and oversight on maintenance of study Trial
Master Files, as appropriate
- Keep current on federal, state, local laws and regulations
governing human-subject research through attendance at conferences,
workshops, seminars, or lectures pertaining to human-subject
- Act as a resource for CSS regarding federal, state, local laws
and regulations governing human-subject research.
- Answer CIRB-related questions, resolve problems and ensure
timely and accurate CIRB submissions and approvals to ensure
adherence to study timelines.
- Act as a liaison with MGH Legal Counsel, the CIRB and sites to
coordinate the finalization and execution of all CIRB Reliance
- Travel to CSS for periodic auditing and site support
activities, as needed.
- Train and mentor Clinical Research APM and staff assistants.
Take on additional tasks and responsibilities, as requested.
- A bachelor's degree is required.
- Minimum of three years experience working in project management
related to clinical research, academic research, or similar
- Background/familiarity with biology or other scientific
discipline is preferred, but not required.
- SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
- A solid understanding of clinical research methodology, FDA and
OHRP regulations as well as ICH GCP is required.
- The ability to multi-task as well as to set and achieve
appropriate goals required.
- Excellent verbal and written communication skills
- Ability to work independently and display initiative
- Ability to identify problems and develop potential
- Sound interpersonal skills and the ability to mentor/supervise
- Good leadership, presentation, and organizational skills.
- Previous experience with electronic IRB submissions preferred
but not required.
- WORKING CONDITIONS:
- Standard Office conditions.
- Will travel on public roads and air travel as needed.
SUPERVISORY RESPONSIBILITY: Training and some oversight/mentoring
of junior staff as appropriate. Primary Location Work Locations :
MGB 165 Cambridge 165 Cambridge Street Boston 02114 Job :
Research-Management Organization : Massachusetts General
Hospital(MGH) Schedule : Full-time Standard Hours : 40 Shift : Day
Job Employee Status : Regular Recruiting Department : MGH Neurology
Keywords: Massachusetts General Physicians' Organization, Cambridge , Clinical Research Regulatory Manager/ Central IRB Liaison, Healthcare , Cambridge, Massachusetts
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