Clinical Research Associate/Monitor II

Site: The General Hospital Corporation

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.

Job Summary

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated clinical trials. PCORP is seeking candidates to conduct monitoring of Cellular Therapy clinical trials.

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

Qualifications

The CRA/Monitor will perform the following duties under general supervision by the Clinical Research Manager:

• Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria a
• Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring is

  Additional Job Details (if applicable)

  EDUCATION:

  • Bachelor's degree required

  EXPERIENCE:

  • Minimum of 2 years of directly related work experience in clinical research (trial coordination, quality assurance and/or monitoring)

  SUPERVISORY RESPONSIBILITY:

  • A Clinical Research Associate/Monitor II may assist with the training and orientation of new staff members

  FISCAL RESPONSIBILITY:

  • Monitors are responsible for conducting onsite monitoring visits in adherence to institutional travel and expense policies and for submitting expense documentation in a timely fashion

  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: WY, ND, Puerto Rico, and the U.S. Virgin Islands.

  · Less than 15% domestic travel (1-2 field visits per quarter)

  · Does not include patient contact

  
  

  Remote Type

  Remote

  
  

  Work Location

  2014 Washington Street

  
  

  Scheduled Weekly Hours

  40

  
  

  Employee Type

  Regular

  
  

  Work Shift

  Day (United States of America)

  
  

  EEO Statement:

  The General Hospital Corporation is an Affirmative Action 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.

  
  

  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.

  Employment Type: Full time