Clinical Research Regulatory Manager/ Central IRB Liaison

Company: Massachusetts General Physicians' Organization
Location: Cambridge
Posted on: May 12, 2022

Job Description:

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 "plain language."
• 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 protection.
• 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 Agreements.
• 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. Qualifications QUALIFICATIONS:
  • A bachelor's degree is required.
  • Minimum of three years experience working in project management related to clinical research, academic research, or similar environment required.
  • 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 solutions
    • Sound interpersonal skills and the ability to mentor/supervise others
    • 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 Research

Keywords: Massachusetts General Physicians' Organization, Cambridge , Clinical Research Regulatory Manager/ Central IRB Liaison, Healthcare , Cambridge, Massachusetts