Mass General Brigham
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Clinical Research Associate I
role at
Mass General Brigham
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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.
Working Conditions: Remote
General Summary/Overview Statement The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.
Principal Duties and Responsibilities
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Regulatory Duties
Maintain and organize study specific regulatory binders
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
Manage adverse event 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
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills / Abilities / Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects’ rights and individual needs
Qualifications Education Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Experience Research Related Experience 1-2 years preferred
Knowledge, Skills And Abilities
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.
Additional Job Details
Remote Type: Remote
Work Location: 101 Merrimac Street
Scheduled Weekly Hours: 40
Employee Type: Regular
Work Shift: Day (United States of America)
Pay Range: $19.76 - $28.44/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 0100 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.
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Clinical Research Associate I
role at
Mass General Brigham
Get AI-powered advice on this job and more exclusive features.
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.
Working Conditions: Remote
General Summary/Overview Statement The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.
Principal Duties and Responsibilities
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Regulatory Duties
Maintain and organize study specific regulatory binders
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
Manage adverse event 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
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills / Abilities / Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects’ rights and individual needs
Qualifications Education Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Experience Research Related Experience 1-2 years preferred
Knowledge, Skills And Abilities
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.
Additional Job Details
Remote Type: Remote
Work Location: 101 Merrimac Street
Scheduled Weekly Hours: 40
Employee Type: Regular
Work Shift: Day (United States of America)
Pay Range: $19.76 - $28.44/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 0100 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.
#J-18808-Ljbffr