Medical Reviewer Clinical Events Department

MedStar Health; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading healthcare organization seeks a Medical Review Coordinator responsible for ensuring the quality and accuracy of clinical data. This role involves collaboration with trial management and oversight of adjudication processes, requiring a Bachelor's degree and substantial experience in clinical or research settings.

Qualifications

• 3-5 years of clinical or research-related experience required.
• No experience in lieu of a degree accepted.
• Demonstrated independent and team work skills.

Responsibilities

• Coordinate medical review of SAE and CEC events to ensure data quality.
• Maintain trial-specific documents and participate in trial start-up activities.
• Oversee medical review of change reports.

Skills

Effective communication

Attention to detail

Prioritization

Teamwork

Education

Bachelor's Degree in Related Field

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.