Safety Monitor lll - Remote

Safety Monitor

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Safety Monitor is responsible for coordinating the safety aspects of projects in conjunction with the Medical Monitor and the project team.

Responsibilities

• 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

Experience

• RN degree, PA degree or bachelor's degree in a scientific discipline with equivalent clinical experience
• Experience in safety/pharmacovigilance, 5-7 years' experience is required
• Working knowledge of MedDRA and WHO drug coding is required.
• Oncology and CTEP AERS experience preferred
• Demonstrated experience with clinical trial data collection
• Excellent knowledge of medical terminology and ability to extract information to create a well written technical narrative/case history
• Excellent clinical judgment and ability to communicate (verbally and in writing) complex clinical issues in a scientifically sound and understandable way
• Working knowledge of HSP and GCP requirements, and site regulatory responsibilities
• Experience with Protocol development and implementation
• Experience with development and writing of complex documents
• Flexibility and collaborative approach

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Unlimited Approved Leave

• Tuition Reimbursement

• 401k & Profit Sharing Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.