CCI Research Regulatory Specialist, Per Diem

Site: The Brigham and Women's Hospital, Inc.

 

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.

 

MGB OCR CCI Regulatory Specialist, per diem

 

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 Women’s Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators.

Summary<br>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. <br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-
The preparation and submission of protocols to the IRB
<br>
-Assists with development of study documents including protocols and informed consent forms <br>
-Advising researchers and research teams on the regulatory review process <br>
-Tracking and facilitating the progress of new trials through the review process
<br>
-Maintain working knowledge of current regulations and MGB IRB policies and guidance’s <br>
-Facilitate training for the research teams on changes to regulatory process or new regulatory requirements <br>
-Track protocol status and alert Investigators and management team of regulatory actions required <br>

 

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 ClinicalTrials.gov 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
Bachelor's Degree Related Field of Study required or Master's 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