Job Description

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.

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.

The Brigham and Women's Hospital, Inc. is an Equal Opportunity 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. #J-18808-Ljbffr Brigham and Women's Hospital

Job Tags

Similar Jobs