Über diese Clinical Research Monitor Stelle bei Mass General Brigham
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
Conduct site monitoring visits in accordance with standards of practice guidelines and federal regulations to ensure that the rights and well-being of human subjects are protected and electronic case report forms (e-CRF) are accurate, complete, and verifiable from source documents.Essential Functions
-Responsible for conducting study monitoring visits to assess protocol and regulatory compliance per the approved monitoring plan.
-Review and compare source documentation to CRFs to ensure data is complete and accurate.
-Draft site monitoring plans
-Provide Investigator and study staff training at study initiation and as needed through the course of the trial
-Review study-specific site documents, including regulatory documents, drug and device accountability logs, training logs, and delegation of authority logs.
-Maintain regular communication with assigned sites to support site enrollment, data entry, query resolution, and patient retention.
-Document site visit findings and observations via trip reports and letters.
-Escalate major visit findings as described in the monitoring plan to appropriate study team members.
-Prepare trip reports and follow-up letters; track issues to closure via CAPA where needed
-Participate in weekly meetings with the study team.
Qualifications
Education
- Bachelor's Degree required; experience can be considered in lieu of a degree
Experience
- At least 1-2 years of clinical research experience required
- Previous experience with monitoring highly preferred
Knowledge, Skills, and Abilities
- Ability to work independently and as a team member.
- Strong attention to detail and organizational skills.
- Knowledge of clinical research protocols.
- Knowledge of data management programs.
- Computer literacy.
- Knowledge of clinical trials, research, and general medicine.
Additional Job Details (if applicable)
Working Conditions
- This is a hybrid role that requires an on-site presence at the office (325 Cambridge Street in Boston) 3x/week
- This is a full-time position with a Monday through Friday schedule during standard Eastern Time business hours
- Remote workdays require a stable, secure, quiet, and HIPAA-compliant workspace. This will be confirmed via Microsoft Teams video for all employees
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$50,502.40 - $82,014.40/Annual
Grade
6
EEO Statement:
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.