Senior Study Monitor

Mass General BrighamBoston, MA
$50,502 - $82,014Hybrid

About The Position

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.

Requirements

  • Bachelor's Degree Related Field of Study required
  • Previous Clinical Research Experience 1-2 years required
  • Previous experience with monitoring 2-3 year 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.
  • Competent and knowledgeable not 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)

Nice To Haves

  • 3-5 years preferred previous clinical research experience
  • Can this role accept experience in lieu of a degree? Yes

Responsibilities

  • 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

Benefits

  • comprehensive benefits
  • career advancement opportunities
  • differentials
  • premiums
  • bonuses as applicable
  • recognition programs
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