Senior Study Monitor

Summary:

The Senior Study Monitor provides centralized oversight of study quality and compliance across up to 15 participating sites. This role ensures protocol adherence, data quality, and consistent operational standards throughout the study.

• Conduct timely centralized monitoring of site performance and protocol adherence
• Review documentation and data quality across participating sites using remote data capture (RDC)
• Able to conduct site visits for monitoring purposes as needed
• Identify trends, risks, or compliance issues and support corrective actions
• Coordinate closely with the Senior Project Manager on study priorities, and adherence to IRB requirements and research Good Clinical Practices (GCP) guidelines
• Maintain monitoring documentation and reporting in accordance with sponsor and institutional standards
• Escalate significant issues through defined governance channels

Travel is expected, including a mix of remote monitoring and periodic onsite visits. Onsite visits are conducted in compliance with Mass General Brigham institutional policies. Flexibility required to coordinate monitoring activities across multiple sites.

Works in close coordination with the Senior Project Manager and research administration team.

• Quality & Compliance
• Attention to Detail
• Analytical Thinking
• Communication

• Competent and knowledgeable about Institutional Review Board general policies and requirements
• Competent and adheres to Research Good Clinical Practices (GCP)
• Familiar with RDC (Remote Data Capture) for monitoring purposes
• Familiar with EDC (Electronic Data Capture) databases and Electronic Medical Records (EMR)

Bachelor's Degree Related Field of Study required.

Can this role accept experience in lieu of a degree? Yes.

• Previous Clinical Research Experience 1-2 years required, 3-5 years preferred
• Previous experience with monitoring 2-3 years preferred

• 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

The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.