Site: Mass General Brigham Incorporated
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.
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 onsite presence at the office (325 Cambridge Street in Boston) 3x/week
Hybrid
325 Cambridge Street
40
Regular
Day (United States of America)
Pay Range
$50,502.40 - $82,014.40/Annual
Grade
6
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.
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.