Safety Monitor

Location
Frederick, MD
Posted
May 05, 2017
Closes
May 08, 2017
Function
Other
Industry
Science
Hours
Full Time

The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO). Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. Emmes is seeking a Safety Monitor.

Primary Responsibilities

The Safety Monitor serves as the primary point of contact with sites to obtain required information for SAE narratives and proper articulation of AEs. In addition, the safety monitor supports all Data Monitoring Committee (DMC) efforts, including the composition of minutes for all DMC meetings (est. 3 per yr).

  • Provide safety review of AEs and first line adjudication of SAEs
  • Maintain ongoing database of SAEs
  • Prepare SAE individual case narrative when required
  • Respond to site and client requests for information regarding safety in clinical trials
  • Participate in the planning and preparation of the safety section of protocols, study procedure manual and other documents
  • Maintain safety related documents for the project in collaboration with Protocol Team
  • Coordinate support to Protocol Teams (external and internal) and clinical trial sites as needed
  • Collaborate with Protocol Monitor/CRA to assure site compliance and understanding of all protocol and regulatory requirements for AE and SAE reporting
  • Participate in development of data reports for the DMC meeting and summarize safety data as required
  • Perform MedDRA coding of adverse events
  • Provide adverse event and clinical trial expertise to training effort
  • Coordinate safety monitoring activities with Medical Monitor (External/Internal)
  • Reviews and confirms essential regulatory documents for collection and upload to RTS/TMF. Supports protocol teams in site activations (ICF reviews)
  • Supports FDA submissions such as Annual IND Report, CSR preparation and ad hoc requests from FDA that relates to patient safety
  • Supports FDA audits

Requirements

  • BA/BS required. Biology-related degree or equivalent clinical experience, RN or other clinical/medical degree (MD, PharmD, etc) preferred
  • Experience in clinical trials research 3-5 years experience is required; safety/pharmacovigilance experience is 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
  • Previous MedDRA coding experience preferred
  • 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

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V

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