Clinical Research Coordinator

Job Title: Clinical Research Coordinator

• Job Summary:

The Clinical Research Coordinator plays a pivotal role in ensuring the smooth execution of clinical trials. This position is responsible for coordinating all aspects of trial management, from documentation and data management to team collaboration and communication.

Key Responsibilities:

• Study Management Documentation: Maintain accurate and up-to-date study documents, adhering to SOPs and work instructions.
• Task Management: Prioritize and manage tasks to meet quality and productivity standards while adhering to project timelines.
• Data Document Management: Support the management of study documents, including TMF documentation, and ensure compliance with eTMF practices.
• System Management: Oversee the operation and maintenance of clinical systems (CTMS, EDC, IWRS, etc.) and user access.
• Study Database Support: Collaborate with the study team to maintain accurate and up-to-date study databases.

Team Collaboration Communication:

• Study Team Support: Provide assistance to the study team with data review and issue resolution, tracking and following up with CRAs as necessary.
• Communication Management: Manage internal and external communications related to the study, ensuring timely updates and escalation when necessary.
• Facilitate Meetings: Coordinate team communication by scheduling meetings, documenting meeting minutes, and distributing relevant information.
• 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: Utilize the XRIM tool to manage and follow up on outstanding action items and protocol deviations.
• Compliance Metrics Support: Monitor compliance metrics related to TMF, CTMS, and project health, ensuring study teams meet training and project requirements.

Study Planning Documentation Support:

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

Additional Responsibilities:

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

Qualifications:

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

Experience:

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

Preferred Qualifications:

• Certification: CRC certification or similar credentials are beneficial.
• Vendor Risk Management: Experience in vendor management and risk identification/management is advantageous.

What You Will Get:

• Competitive Compensation Package: A package based on skills and experience.

Benefits:

• Health Insurance: Medical, dental, and vision insurance.
• Life Insurance: Life insurance and STD/LTD benefits.
• 401(K) Plan: 401(K) plan with company match.
• Paid Time Off: Paid time off or flexible time off.
• Employee Stock Purchase Plan: Employee stock purchase plan.
• Company Bonus: Company bonus where applicable.