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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:

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 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

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 Clinical Trials.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 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

Hybrid

Work Location

221 Longwood Avenue

Scheduled Weekly Hours

0

Employee Type

Per Diem

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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.