Key Responsibilities: Study Management Documentation:

Follow SOPs and Work Instructions: Adhere to all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
Task Management: Complete day-to-day tasks to ensure quality and productivity while meeting timelines as required.
Data Document Management: Support in managing study documents and maintaining trial master file (TMF) documentation. Ensure compliance with eTMF management practices.
System Management: Manage clinical systems (CTMS, IWRS, EDC, etc.) and user access.
Study Database Support: Assist in maintaining study databases, ensuring they are up-to-date and accurate.

Team Collaboration Communication:

Study Team Support: Provide support to the study team with data review and resolution of issues. Track and follow up with Clinical Research Associates (CRAs) for outstanding items.
Communication Management: Manage internal and external communications related to the study, ensuring timely updates and escalation when necessary.
Facilitate Meetings: Support team communication by setting up meetings, documenting meeting minutes, and ensuring proper distribution.
Vendor Management Oversight: Assist with vendor management, including tracking vendor performance and ensuring payments are processed for sites and vendors.

Project Management Compliance:

Timelines Milestone Updates: Update project timelines, milestones, and trackers within project management tools, ensuring alignment across the team and escalating any risks.
Risk Identification Resolution: Use the Xcellerate Risk Identification Issue Resolution (XRIM) tool to manage and follow up on outstanding action items and protocol deviations.
Compliance Metrics Support: Actively monitor compliance metrics related to TMF, CTMS, and project health. Ensure study teams are in compliance with training and project requirements.

Study Planning Documentation Support:

Study Plans Documentation: Assist Functional Leads in drafting project plans and coordinating review, feedback, and execution between the study team and clients.
WISER Moments Support: Help maintain WISER moments and contribute to study planning and process improvement efforts.

Additional Responsibilities:

Process Improvement: Contribute to process improvement opportunities and assist in the implementation of new or revised processes and procedures.
Cross-Functional Support: May assist with additional cross-functional tasks as required by the project.

Qualifications: Required:

Education: Bachelor s degree or equivalent experience in a related field (Life Sciences, Healthcare, etc.).

Experience:

Previous experience in clinical trial coordination or a related field (clinical operations, project management, etc.).
Knowledge of clinical trial processes and clinical systems (CTMS, EDC, IWRS, etc.).
Ability to work in a fast-paced environment and manage multiple priorities simultaneously.
Strong organizational skills with an ability to track and report metrics according to deadlines.

Preferred:

Certifications: Clinical Research Coordinator (CRC) certification or similar credentials are a plus.
Experience with Vendor Risk Management: Experience in vendor management and risk identification/management is beneficial.

What You Will Get:

Comprehensive Benefits Package including:

Clinical Trial Coordinator