<p>Site: The Brigham and Women's Hospital, Inc.</p> <p>Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.</p> <p>Job Summary</p> <p>Summary</p> <p>Responsible for the coordination of medical review of SAE and CEC events/packets to ensure quality, accuracy, and completeness of data and source documentation. This individual will collaborate with the Chairman to perform various tasks associated with trial start-up and ongoing quality control. Additionally, this individual will work collaboratively with the Managers to ensure timely medical review of events within the medical review team in order to meet trial-specific adjudication timelines.</p> <p>Does this position require Patient Care?</p> <p>No</p> <p>Essential Functions</p> <ul> <li>Ensure adequate staff coverage to complete required and anticipated medical review case load. </li><li>Maintain trial-specific CEC Charters and operations manuals. </li><li>Participate in trial start-up activities including review of adjudication forms and user acceptance testing. </li><li>Assist the Chairman in the development and review of logic/consistency checks involving adjudicated data. </li><li>Provide oversight for the medical review of change reports and address issues. </li><li>Collaborate in the development of departmental SOPs and work instructions. </li><li>Serve as a resource for internal staff, investigational sites, monitors, and study staff within Sponsor departments regarding the submission of source data for CEC events. </li></ul> <p>Qualifications</p> <p>Education</p> <p>Bachelor's Degree Related Field of Study required</p> <p>Can this role accept experience in lieu of a degree?</p> <p>No</p> <p>Licenses and Credentials</p> <p>Experience</p> <p>Clinical and/or research-related experience including clinical endpoint adjudication and/or serious adverse event processing 3-5 years required</p> <p>Knowledge, Skills and Abilities</p> <ul> <li>Demonstrated ability to communicate effectively. </li><li>Demonstrated ability to pay meticulous attention to detail. </li><li>Demonstrated ability to prioritize work to meet trial/department deadlines. </li><li>Demonstrated ability to work independently and within a team. </li></ul> <p>Additional Job Details (if applicable)</p> <p>Remote Type</p> <p>Remote</p> <p>Work Location</p> <p>350 Longwood Avenue</p> <p>Scheduled Weekly Hours</p> <p>40</p> <p>Employee Type</p> <p>Regular</p> <p>Work Shift</p> <p>Day (United States of America)</p> <p>EEO Statement:</p> <p>The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.</p> <p>Mass General Brigham Competency Framework</p> <p>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.</p>