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Regulatory Affairs Coordinator - Urology
Mass General Brigham
10 hours ago
Full-time
On-site
Boston, Massachusetts, United States
Registered Nurse
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.
Job Summary
The Regulatory Affairs Coordinator I works under general supervision to ensure
the regulatory requirements for clinical trials are met. This position involves
working with clinical teams, Institutional Review Boards (IRB), clinical trial
sponsors, and federal regulatory agencies.
Will be trained on the institutional and federal regulations governing clinical
research.
Does this position require Patient Care?
No
Essential Functions
-Prepare and submit protocol amendments, continuing reviews, and safety reports
to the IRB.
- Revise informed consent documents to include new risk information and/or
updated protocol requirements through the course of the study.
- Maintains regulatory documentation for assigned studies in accordance with
institutional requirements, sponsor requirements, federal regulations, and GCP
guidelines.
-Manage adverse events and deviation/violation/exception documentation for all
enrolled patients and report to the sponsor and IRB as required.
-Submit Data and Safety Monitoring Reports.
-Maintain source documentation of correspondence with the IRB, investigators,
and sponsors throughout the clinical trial process.
-Collect, complete, and submit essential regulatory documents to various
regulatory entities.
-Participate in monitoring visits and file all monitoring visit correspondence.
- Tracks regulatory deadlines and study milestones, including continuing
reviews, protocol amendments, personnel changes, training expirations, and other
required submissions.
- Works with Clinical Research Coordinators, investigators, and other study team
members to collect information and documentation needed for regulatory
submissions.
- Maintains current study personnel documentation, including CITI/GCP training,
CVs, medical licenses, delegation of authority logs, conflict-of-interest
documentation, and other required records.
- Assists with maintaining study information in applicable institutional
research systems and regulatory tracking tools.
- Prepares and maintains electronic and/or paper regulatory binders and ensures
documents are complete, current, appropriately signed and dated, and readily
available for review.
- Assists with processing study personnel additions and removals and ensures
corresponding regulatory documentation and systems are updated.
- Supports submission and tracking of protocol deviations, safety reports,
reportable events, and other regulatory documentation under the guidance of
senior regulatory staff.
- Communicates with study teams regarding upcoming regulatory deadlines and
outstanding documentation.
- Maintains accurate regulatory tracking spreadsheets and databases.
- Assists with regulatory study close-out activities and maintenance of required
records.
- Other duties as assigned.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Experience
0-1 yrs of experience.
Knowledge, Skills and Abilities
- Careful attention to detail.
- Good organizational skills.
- Ability to follow directions.
- Computer literacy.
- Working knowledge of clinical research protocols.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
20 Shattuck Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$20.16 - $29.01/Hourly
Grade
5
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.
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
The Regulatory Affairs Coordinator I works under general supervision to ensure
the regulatory requirements for clinical trials are met. This position involves
working with clinical teams, Institutional Review Boards (IRB), clinical trial
sponsors, and federal regulatory agencies.
Will be trained on the institutional and federal regulations governing clinical
research.
Does this position require Patient Care?
No
Essential Functions
-Prepare and submit protocol amendments, continuing reviews, and safety reports
to the IRB.
- Revise informed consent documents to include new risk information and/or
updated protocol requirements through the course of the study.
- Maintains regulatory documentation for assigned studies in accordance with
institutional requirements, sponsor requirements, federal regulations, and GCP
guidelines.
-Manage adverse events and deviation/violation/exception documentation for all
enrolled patients and report to the sponsor and IRB as required.
-Submit Data and Safety Monitoring Reports.
-Maintain source documentation of correspondence with the IRB, investigators,
and sponsors throughout the clinical trial process.
-Collect, complete, and submit essential regulatory documents to various
regulatory entities.
-Participate in monitoring visits and file all monitoring visit correspondence.
- Tracks regulatory deadlines and study milestones, including continuing
reviews, protocol amendments, personnel changes, training expirations, and other
required submissions.
- Works with Clinical Research Coordinators, investigators, and other study team
members to collect information and documentation needed for regulatory
submissions.
- Maintains current study personnel documentation, including CITI/GCP training,
CVs, medical licenses, delegation of authority logs, conflict-of-interest
documentation, and other required records.
- Assists with maintaining study information in applicable institutional
research systems and regulatory tracking tools.
- Prepares and maintains electronic and/or paper regulatory binders and ensures
documents are complete, current, appropriately signed and dated, and readily
available for review.
- Assists with processing study personnel additions and removals and ensures
corresponding regulatory documentation and systems are updated.
- Supports submission and tracking of protocol deviations, safety reports,
reportable events, and other regulatory documentation under the guidance of
senior regulatory staff.
- Communicates with study teams regarding upcoming regulatory deadlines and
outstanding documentation.
- Maintains accurate regulatory tracking spreadsheets and databases.
- Assists with regulatory study close-out activities and maintenance of required
records.
- Other duties as assigned.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Experience
0-1 yrs of experience.
Knowledge, Skills and Abilities
- Careful attention to detail.
- Good organizational skills.
- Ability to follow directions.
- Computer literacy.
- Working knowledge of clinical research protocols.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
20 Shattuck Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$20.16 - $29.01/Hourly
Grade
5
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.