Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelors Degree required
• Clinical Research Postgraduate Certificate preferred
• Knowledge of ICH-GCP required
• Experience with EDC systems strongly preferred1+ years of experience with a pharmaceutical manufacturer, Biotech, or CRO required

• Assist in the creation, ongoing management and closeout of databases of Sitero’s eClinical projects, by working closely with the Data Management Team and team members
• Project Planning / Timelines
• Support in the coordination of key documents that define study timelines and responsibilities
• Assist in the tracking of study timelines and deliverables
• Coordination and support of internal / client meetings
• Web-based and in-person meeting support
• Development of meeting support materials (Minutes, Actions)
• External Communication
• Prepare draft communication in a timely and effective manner with the Client, Vendors and Sites
• Support Sitero’s application support:
• eCRF/Module Configuration
• eCRF/Module Validation/Testing
• Validation of Sitero’s outputs ie. Reports, Data Listings, SAS, etc.
• Sitero’s eClinical Suite deployment support and build testing
• Development of eCRF related tools, including: Source Documents, Study Completion Guidelines and Tips & Tools / User GuidesIssue Management: Work with the Project and Customer Care Teams to respond to project-related end-user inquiries