CCI Research Regulatory Specialist, Per Diem
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Job Location:
Boston, NH - USA
Yearly Salary:
USD 3 - 5
Posted on:
9 days ago
Vacancies:
1 Vacancy
Job Summary
Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
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 Womens 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.
Does this position require Patient Care
No
Essential Functions
-
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 guidances
-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
Qualifications
The Regulatory Specialist will be responsible for research studies and clinical trial start-up and maintenance by supporting the design planning and management of the projects.
Principal Duties and Responsibilities:
Acts as a liaison between the investigators sites and sponsors. This includes:
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
Regulatory
Submit IRB Applications and required reporting including commercial IRB submissions and cede review applications
Manage site regulatory documents and binders
Manage postings
Study documents
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
Education
Bachelors Degree Related Field of Study required or Masters Degree Related Field of Study preferred
Can this role accept experience in lieu of a degree
No
Experience
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
Knowledge Skills and Abilities
- 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
Additional Job Details (if applicable)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$63252.80 - $102596.00/AnnualGrade
7EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham our competency framework defines what effective leadership looks like by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance make hiring decisions identify development needs mobilize employees across our system and establish a strong talent pipeline.
Required Experience:
IC
About Company
Patients at Mass General have access to a vast network of physicians, nearly all of whom are Harvard Medical School faculty and many of whom are leaders within their fields.
