Clinical Research Associate/Monitor II

4 days ago


Boston, United States Mass General Brigham Full time

Clinical Research Associate/Monitor II Apply remote type Remote locations Boston-MA time type Full time posted on Posted 2 Days Ago job requisition id RQ3310826 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 Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring is Collaborate with study team to schedule monitoring 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, track and resolve queries 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 maintenance Assist team with other regulatory or coordination tasks as needed SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Careful attention to details Superior organizational and time management skills and ability to prioritize multiple tasks Analytical skills, including the ability to gather information, identify resources, and develop alternatives Excellent written and oral communication skills Able to work successfully in a fully 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 Excellent judgment and ability to interpret information and protocol requirements 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. #J-18808-Ljbffr



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