Mass General Brigham
This
Research Regulatory Specialist
position at
Mass General Brigham
supports the Office of Clinical Research (OCR) by ensuring that all regulatory documentation is accurately prepared, maintained, and submitted in compliance with ICH Good Clinical Practice, FDA, IRB, and institutional guidelines.
Job Summary Guide investigators through the IRB review process and assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance.
Essential Functions
Preparation and submission of protocols to the IRB.
Assists with development of study documents including protocols and informed consent forms.
Advises researchers and research teams on the regulatory review process.
Tracks and facilitates the progress of new trials through the review process.
Maintains working knowledge of current regulations and MGB IRB policies and guidance.
Facilitates training for the research teams on changes to regulatory process or new regulatory requirements.
Tracks protocol status and alerts investigators and management team of regulatory actions required.
Qualifications Education:
Bachelor’s Degree in a related field required; Master’s Degree preferred.
Experience:
3-5 years of regulatory or clinical research experience with an academic medical center or industry.
Knowledge, Skills & Abilities:
High level time management and organization skills.
Excellent written and verbal communication skills.
Knowledge of current and developing clinical research trends.
Sound interpersonal skills.
Ability to work independently and display initiative.
Ability to identify problems and develop solutions.
Additional Job Details Remote Type:
Hybrid
Work Location:
125 Nashua Street
Scheduled Weekly Hours:
0
Employee Type:
Per Diem
Work Shift:
Day (United States of America)
Pay Range:
$62,004.80 - $90,750.40 Annual
Grade:
7
Compensation & Benefits At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Base pay is competitive and may be adjusted for skills, experience, education, and other factors. In addition to base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums, bonuses as applicable, and recognition programs designed to celebrate your contributions and support your professional growth.
EEO Statement 1200 The General Hospital Corporation 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.
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Research Regulatory Specialist
position at
Mass General Brigham
supports the Office of Clinical Research (OCR) by ensuring that all regulatory documentation is accurately prepared, maintained, and submitted in compliance with ICH Good Clinical Practice, FDA, IRB, and institutional guidelines.
Job Summary Guide investigators through the IRB review process and assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance.
Essential Functions
Preparation and submission of protocols to the IRB.
Assists with development of study documents including protocols and informed consent forms.
Advises researchers and research teams on the regulatory review process.
Tracks and facilitates the progress of new trials through the review process.
Maintains working knowledge of current regulations and MGB IRB policies and guidance.
Facilitates training for the research teams on changes to regulatory process or new regulatory requirements.
Tracks protocol status and alerts investigators and management team of regulatory actions required.
Qualifications Education:
Bachelor’s Degree in a related field required; Master’s Degree preferred.
Experience:
3-5 years of regulatory or clinical research experience with an academic medical center or industry.
Knowledge, Skills & Abilities:
High level time management and organization skills.
Excellent written and verbal communication skills.
Knowledge of current and developing clinical research trends.
Sound interpersonal skills.
Ability to work independently and display initiative.
Ability to identify problems and develop solutions.
Additional Job Details Remote Type:
Hybrid
Work Location:
125 Nashua Street
Scheduled Weekly Hours:
0
Employee Type:
Per Diem
Work Shift:
Day (United States of America)
Pay Range:
$62,004.80 - $90,750.40 Annual
Grade:
7
Compensation & Benefits At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Base pay is competitive and may be adjusted for skills, experience, education, and other factors. In addition to base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums, bonuses as applicable, and recognition programs designed to celebrate your contributions and support your professional growth.
EEO Statement 1200 The General Hospital Corporation 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.
#J-18808-Ljbffr