Clinical Research Monitor - Cancer Center Protocol Office
Massachusetts General Hospital(MGH)

Boston, Massachusetts

This job has expired.


GENERAL DESCRIPTION:

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates to monitor oncology trials.

The Multi-center Clinical Research Associate/Monitor works under general supervision to provide regulatory oversight and monitoring for a portfolio of Investigator-initiated, multi-center clinical research trials. The Monitor position ensures Sponsor and site regulatory adherence, verifies source documentation, monitors data quality and completeness and assesses protocol compliance across participating trial sites. The role focuses on trial quality assurance and does not include direct patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Principal responsibilities include:

  • Verify patient consent and eligibility via source document review and clinical analysis of case data
  • Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel (< 25%) may be required for onsite monitoring)
    • Collaborate with study team to schedule monitoring visit, pharmacy visit and exit interview
    • Perform source document verification
    • Review study site regulatory and essential documents for completeness and accuracy
    • Perform drug accountability and DARF verification
    • Evaluate ongoing protocol and data compliance
    • Issue and resolve queries
    • Formulate and implement corrective action plans if needed
  • Formulate and implement corrective action plans for major non-compliance; ensure follow-through by study team
  • Communicate and escalate ongoing compliance issues to study leadership
  • Provide guidance and consultation on best practices for data capture and documentation
  • Assist team with other regulatory or coordination tasks as needed
WORKING CONDITIONS:
  • Duties will mainly be performed in a remote setting. Limited on-site presence anticipated.
  • Applicants may work in all states with the following exceptions: OH, WY, WA, ND, Puerto Rico, and the U.S. Virgin Islands
  • Up to 25% domestic travel (1-2 field visits per month)
  • Does not include patient contact


Qualifications
SKILLS AND COMPETENCIES REQUIRED:
  • Careful attention to details
  • Superior organizational and time management skills and ability to prioritize multiple tasks
  • Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives
  • Excellent written and oral communication skills
  • Able to work successfully in a remote environment
  • Demonstrate initiative and accountability
  • Working knowledge of clinical research protocols
  • Ability and willingness to travel nationally
  • Ability to work independently with general supervision
  • Analytical skills and ability to identify and resolve problems and develop alternatives
  • Excellent judgment and ability to interpret information and protocol requirements
EDUCATION AND EXPERIENCE:

  • Bachelor's degree rquired
  • Minimum of 1-2 years of directly related work experience in clinical research (coordination, regulatory, quality assurance and/or monitoring


EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.


This job has expired.

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