TELECOMMUTE – US National
Safety Monitor (Home-Based)
Position LocationUnited States – Remote
Job Code 2746
# of openings 2
The Emmes Company, LLC (?Emmes?) is searching for a Safety Monitor. Emmes provides flexibility for the office location or work remote preference dependent upon position.
Emmes, established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over eight hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Safety Monitor is responsible for coordinating the safety aspects of projects in conjunction with the Medical Monitor and the project team.
Coordinates safety monitoring activities with Project Medical Monitor
Reviews safety events
Provides first line evaluation of serious adverse events (SAEs)
Communicates with site staff regarding reported AEs or SAEs to gather additional information
Prepares a summary narrative for each reported SAE suitable for inclusion in DSMB reports, regulatory submissions and final study reports
Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
Reviews adverse events for the study on a regular basis
Communicates with sponsor, investigator site staff, pharmaceutical and other study partners
Responds to site, sponsor, pharmaceutical partner requests for information regarding safety in clinical trials
Participates in Data Safety Monitoring Board (DSMB) or other safety review committee (SRC) meetings as necessary
Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report, and periodic safety reports
Coordinates with project staff
Participates in project team meetings
Participate in the planning, preparation, and development of all safety-related sections of protocols, study specific Manual of Operations (MOP), project SOPs, and ancillary documents to ensure project compliance with corporate SOPs
Contribute to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SMP)
Maintains documentation required by corporate and project SOPs
Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities
Performs MedDRA and WHO Drug coding, as applicable
Other corporate activities including annual SOP reviews, development and teaching EmmesU classes, participation in corporate safety meetings/activities; and other corporate PV activities
Other duties as assigned
RN degree, PA degree or ba…
Medical & Health , Medical Research , Nursing , Pharmaceutical , Science