Medical Project Coordinator (Mid/Night Shift)
Medical Project Coordinator (Mid/Night Shift)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
A day in the Life:
- 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.
Education
- Bachelors degree in Nursing or related Health Sciences (Physicians Assistant) or licensed RN
Experience
- 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)
Knowledge Skills Abilities
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending to include coding
- Working knowledge of biostatistics data management and clinical procedures
- Strong problem solving and critical thinking skills
- Good oral and written communication skills
- Good Strong attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
Required Experience:
IC
Employment Type
Full-Time
