Mass General Brigham
Clinical Research Regulatory Coordinator I
Mass General Brigham, Boston, Massachusetts, us, 02298
Clinical Research Regulatory Coordinator I
Join to apply for the
Clinical Research Regulatory Coordinator I
role at
Mass General Brigham
Job Summary The Clinical Research Regulatory Coordinator I (CRRCI) 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. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Principal Duties And Responsibilities
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
Qualifications Education: Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Licenses and Credentials: n/a
Working Conditions Duties will be performed remotely
Job Details Work Location: 101 Merrimac Street
Scheduled Weekly Hours: 40
Employee Type: Regular
Work Shift: Day (United States of America)
Remote Type: Remote
Compensation 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. Base pay is estimated based on minimum qualifications and does not encompass all additional compensation such as bonuses, premiums, and benefits.
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, or any other status protected under law. Reasonable accommodation for individuals with disabilities is provided throughout the application and interview process. For accommodation requests, 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 behaviors critical for successful performance at each job level. The framework comprises ten competencies and is used to evaluate performance, make hiring decisions, identify development needs, and build a strong talent pipeline.
#J-18808-Ljbffr
Clinical Research Regulatory Coordinator I
role at
Mass General Brigham
Job Summary The Clinical Research Regulatory Coordinator I (CRRCI) 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. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Principal Duties And Responsibilities
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
Qualifications Education: Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Licenses and Credentials: n/a
Working Conditions Duties will be performed remotely
Job Details Work Location: 101 Merrimac Street
Scheduled Weekly Hours: 40
Employee Type: Regular
Work Shift: Day (United States of America)
Remote Type: Remote
Compensation 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. Base pay is estimated based on minimum qualifications and does not encompass all additional compensation such as bonuses, premiums, and benefits.
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, or any other status protected under law. Reasonable accommodation for individuals with disabilities is provided throughout the application and interview process. For accommodation requests, 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 behaviors critical for successful performance at each job level. The framework comprises ten competencies and is used to evaluate performance, make hiring decisions, identify development needs, and build a strong talent pipeline.
#J-18808-Ljbffr