Medical Project Coordinator

• Coordinate and review safety data using line listings, company dashboards, and visualization tools
• Review data for safety trends, coding consistencies, and potential investigator-site follow-up
• Identify, resolve, or escalate potential issues
• Provide safety-data summaries for safety review meetings
• Review designated sections of aggregate reports
• Help create and review safety and medical management plans for studies
• Ensure plan processes reflect contracted services
• Help manage routine project implementation, forecasting, and coordination
• Review metrics and budget considerations
• Monitor data-review status and escalate delays or risks to stakeholders and study leads
• Present at business development, client, and investigator meetings
• Participate in strategy and business development calls
• Resolve complex problems through in-depth evaluation and offer solutions
• Serve as a primary contact for clinical/data management project teams
• Assist management with training and mentoring

• Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
• 2+ years of previous experience comparable to the role
• 2+ years of clinical safety experience, including clinical research monitoring, pharmacovigilance, or a combination of both
• Equivalency combining appropriate education, training, and/or directly related experience may be considered
• Knowledge of GCPs for medical oversight of clinical trials and SAE processing
• Knowledge of drug development and safety reporting
• Knowledge of safety data trending, including coding
• Working knowledge of biostatistics, data management, and clinical procedures
• Strong problem-solving and critical-thinking skills
• Good oral and written communication skills
• Good attention to detail
• Ability to work collaboratively
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to perform repetitive hand movements and frequent mobility
• Ability to lift and carry objects weighing up to 15–20 lbs
• Ability to use computer software
• Regular and consistent attendance

• Collaboration and development opportunities
• Opportunity to contribute to scientific excellence and patient safety
• Global team environment