CCI Research Regulatory Specialist, Per Diem

Mass General Brigham•Boston, MA

1d•Hybrid

About The Position

We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Regulatory Specialist in the Mass General Brigham (MGB) Office of Clinical Research (OCR) Center for Clinical Investigation (CCI). The candidate will work with the Research Operations Director, Department Managers, and Principal Investigators. The mission of the MGB OCR CCI is to strengthen the culture for clinical research at the Brigham and Women’s Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators. Summary Will guide investigators in the IRB review process and will assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance.

Requirements

Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred
Prior regulatory or clinical research experience with an academic medical center or industry 3-5 years required and high proficiency with Microsoft Office, particularly with Excel
Outstanding organizational skills are necessary to manage detailed information and priorities across competing timetables and responsibilities.
Ability to plan for the timely and successful completion of short- and long-term objectives.
Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency, including senior hospital leaders, division faculty and support staff, representatives of other BWH offices, collaborating institution officials, granting agencies (NIH, industry and foundations) representatives, and vendors.
Requires the ability to work independently to ensure protocol review, implementation and ancillaries processes run smoothly.
High degree of analytic ability to manage the financial and human resources aspects of the position.
Interpersonal relationship skills needed to collaborate with others and work with functional group managers, many hospital-wide department heads, administrators, and physicians in a positive and collegial fashion.
Comfortable using systems to create, update, maintain and disseminate data and reports.
Sound interpersonal skills
Works well independently and in groups; displaying initiative and diplomacy while maintaining important work relationships
Demonstrated ability to successfully manage multiple projects

Responsibilities

The preparation and submission of protocols to the IRB
Assists with development of study documents including protocols and informed consent forms
Advising researchers and research teams on the regulatory review process
Tracking and facilitating the progress of new trials through the review process
Maintain working knowledge of current regulations and MGB IRB policies and guidance’s
Facilitate training for the research teams on changes to regulatory process or new regulatory requirements
Track protocol status and alert Investigators and management team of regulatory actions required
Acts as a liaison between the investigators, sites, and sponsors.
Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.
Meeting with the research team regularly to review trial projects, timelines and action items
Manage regulatory, compliance and sponsor study start-up activities
Lead additional special project oversight as requested
Submit IRB Applications and required reporting, including commercial IRB submissions and cede review applications
Manage site regulatory documents and binders
Manage ClinicalTrials.gov postings
Assist in preparation of protocol and informed consent forms
Assist with recruitment materials
Oversee preparation and maintenance of Manuals of Procedures
Oversee site and staff training materials
Manage study portal and access to study documents and trial materials