Clinical Trial Coordinator

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:

• Competitive Compensation Package

  based on skills and experience.

Comprehensive Benefits Package

• Health insurance (Medical, Dental, Vision)
• Life Insurance, STD/LTD
• 401(K) plan
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Employee Stock Purchase Plan (ESPP)
• Company bonus (where applicable)