Mass General Brigham Health Plan, Inc.
Clinical Research Activation Coordinator II
Mass General Brigham Health Plan, Inc., Boston, Massachusetts, us, 02298
You may choose to display a cookie banner on the external site. You must specify the message in the cookie banner and may add a link to a relevant policy. If you are unfamiliar with these requirements, please seek the advice of legal counsel. )Site: Mass General Brigham IncorporatedMass 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.General Summary/Overview Statement:
The Clinical Research Activation Coordinator II (CRAC II) works independently under general supervision to ensure the regulatory and operational requirements for clinical trials are met prior to activation. This position may also involve post-activation regulatory responsibilities. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRAC II will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact.
Working Conditions
Duties will be performed remotely**Job Summary**Works independently 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. This position does not include any direct patient contact.
Essential Functions
-Monitor and maintain compliance with applicable local, national, and international regulations, as well as institutional policies and guidelines related to clinical research.
-Prepare, review, and submit all necessary regulatory documentation required for initiating and conducting clinical trials.
-Facilitate the submission of study protocols and related documents to the Institutional Review Board (IRB) or Ethics Committee, ensuring compliance with ethical and safety considerations for human subjects involved in the research.
-Maintain accurate and up-to-date regulatory documentation, including informed consent forms, protocol amendments, safety reports, and other essential study-related documents.
-Prepare and submit timely and accurate regulatory reports, including adverse event reports and safety updates, as required by regulatory authorities and institutional policies.
-Act as a liaison between the research team, principal investigators, sponsors, and regulatory authorities.
-Provide guidance and training to research staff, investigators, and study team members on regulatory matters, best practices, and changes in regulations that may impact the conduct of clinical research.**Qualifications**Education
Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required
Licenses and Credentials
Experience
Regulatory Affairs Experience 2-3 years required
Knowledge, Skills and Abilities
- Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.).
- Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity.
- Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Proficiency in using relevant software and electronic systems for regulatory documentation management.
- Ability to interpret the acceptability of data results.**Additional Job Details (if applicable)****Remote Type**Remote**Work Location**101 Merrimac Street**Scheduled Weekly Hours**40**Employee Type**Regular**Work Shift**Day (United States of America)**Pay Range**$23.80 - $34.81/Hourly**Grade**6At 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:**Mass General Brigham Incorporated 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.Combat disease. Hold a hand. Help people. Impact the world.Mass General Brigham is a passionate, welcoming community where minds meet caring hearts.Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world.Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community.We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system.We recognize that increasing value and continuously improving quality are essential to maintaining excellence. #J-18808-Ljbffr
The Clinical Research Activation Coordinator II (CRAC II) works independently under general supervision to ensure the regulatory and operational requirements for clinical trials are met prior to activation. This position may also involve post-activation regulatory responsibilities. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRAC II will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact.
Working Conditions
Duties will be performed remotely**Job Summary**Works independently 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. This position does not include any direct patient contact.
Essential Functions
-Monitor and maintain compliance with applicable local, national, and international regulations, as well as institutional policies and guidelines related to clinical research.
-Prepare, review, and submit all necessary regulatory documentation required for initiating and conducting clinical trials.
-Facilitate the submission of study protocols and related documents to the Institutional Review Board (IRB) or Ethics Committee, ensuring compliance with ethical and safety considerations for human subjects involved in the research.
-Maintain accurate and up-to-date regulatory documentation, including informed consent forms, protocol amendments, safety reports, and other essential study-related documents.
-Prepare and submit timely and accurate regulatory reports, including adverse event reports and safety updates, as required by regulatory authorities and institutional policies.
-Act as a liaison between the research team, principal investigators, sponsors, and regulatory authorities.
-Provide guidance and training to research staff, investigators, and study team members on regulatory matters, best practices, and changes in regulations that may impact the conduct of clinical research.**Qualifications**Education
Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required
Licenses and Credentials
Experience
Regulatory Affairs Experience 2-3 years required
Knowledge, Skills and Abilities
- Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.).
- Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity.
- Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Proficiency in using relevant software and electronic systems for regulatory documentation management.
- Ability to interpret the acceptability of data results.**Additional Job Details (if applicable)****Remote Type**Remote**Work Location**101 Merrimac Street**Scheduled Weekly Hours**40**Employee Type**Regular**Work Shift**Day (United States of America)**Pay Range**$23.80 - $34.81/Hourly**Grade**6At 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:**Mass General Brigham Incorporated 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.Combat disease. Hold a hand. Help people. Impact the world.Mass General Brigham is a passionate, welcoming community where minds meet caring hearts.Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world.Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community.We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system.We recognize that increasing value and continuously improving quality are essential to maintaining excellence. #J-18808-Ljbffr