Medical Reviewer Clinical Events Department

Brigham and Women's Hospital; Boston (MA); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading hospital in Boston is seeking a detail-oriented professional to coordinate medical reviews for clinical trials. This role involves ensuring data accuracy, collaborating with the medical review team, and maintaining trial documentation. The ideal candidate will have a Bachelor's degree and significant clinical experience. Join a passionate community dedicated to advancing patient care and research.

Qualifications

• 3-5 years of clinical/research experience required.
• Experience in clinical endpoint adjudication and serious adverse event processing.

Responsibilities

• Coordinate medical review of SAE and CEC events.
• Maintain trial-specific CEC Charters and operations manuals.
• Collaborate with the Chairman for trial start-up activities.

Skills

Communication

Attention to Detail

Prioritization

Education

Bachelor's Degree Related Field of Study

Job description

Site: The Brigham and Women's Hospital, Inc. 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. Job Summary Summary
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.

Does this position require Patient Care?
No

Essential Functions
-Ensure adequate staff coverage to complete required and anticipated medical review case load.
-Maintain trial-specific CEC Charters and operations manuals.
-Participate in trial start-up activities including review of adjudication forms and user acceptance testing.
-Assist the Chairman in the development and review of logic/consistency checks involving adjudicated data.
-Provide oversight for the medical review of change reports and address issues.
-Collaborate in the development of departmental SOPs and work instructions.
-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.
Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical and/or research-related experience including clinical endpoint adjudication and/or serious adverse event processing 3-5 years required Knowledge, Skills and Abilities - Demonstrated ability to communicate effectively. - Demonstrated ability to pay meticulous attention to detail. - Demonstrated ability to prioritize work to meet trial/department deadlines. - Demonstrated ability to work independently and within a team. Additional Job Details (if applicable) Remote Type Remote Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) EEO Statement: 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. 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. Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence.