Regulatory Manager

Responsibilities 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 for adherence to institutional policies and procedures, applicable federal regulations, 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 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.
• 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 the study teams regarding federal, state, 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 Assistant Regulatory Managers.
• Take on additional tasks and responsibilities, as requested.

Skills and Competencies:

• 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.

Experience (Required):

• A bachelor's degree is required.
• At least three years of experience working in clinical research or similar environment required.