**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Essential Functions and Other Job Information**:
- Coordinates and reviews safety data, utilizing line listings, company
dashboard(s) and/or other visualization tools. Reviews data for safety trends,
coding consistencies, and potential follow up with investigator sites. Identifies
potential issues and resolves or escalates as appropriate.
Reviews safety data and may provide summations for safety review meetings.
May review designated sections of aggregate reports.
May help to create/review safety and medical management plan(s) on studies
(as applicable) and ensures that the processes included in plan documents are
reflective of the contract and services requested.
May help manage routine project implementation, forecasting and coordination,
including review of metrics and budget considerations.
Monitors the status of the data review and escalates any delays and/or risks to
all stakeholders, including study leads.
May present at business development, client, and investigator meetings and
participate in strategy/business development calls.
Resolves complex problems through in-depth evaluation of various factors and
offers solutions.
May serve as the primary point of contact for clinical/data management project
teams.
May assist management in training and mentoring
**Qualifications**:
**Education and Experience**:
Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
**Working Conditions and Environment**:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.