Medical Project Coordinator
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Job Description
Medical Project Coordinator position focused on enhancing drug safety operations. Responsibilities include data review, project implementation, and compliance with regulatory standards.
Responsibilities:
- Coordinate and review safety data, utilizing line listings, company dashboards and/or other visualization tools
- Review data for safety trends, coding consistencies, and potential follow up with investigator sites
- Identify potential issues and resolve or escalate as appropriate
- Review 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 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
- Monitor the status of the data review and escalate 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
- Resolve 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
Requirements:
- Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
Benefits:
- Health insurance
- Professional development opportunities
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