Clinical Research Monitor

The Clinical Research Monitor supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents. This position is primarily remote but must travel to research sites and St. Jude as needed.

Job Responsibilities:

• Monitor the protocol and regulatory compliance of clinical research studies (with lowest to high-risk research designs), in multiple treatment areas.
• Review research data Electronic Data Capture (EDC) system abstracted from source documentation for accuracy, completeness, and timeliness.
• Track, update, and manage documentation, study status and key milestones within CTMS, eTMF, and other systems and applications as needed.
• Collect, review, maintain, and audit essential documents.
• Write detailed monitoring reports for assigned studies.
• Determine data to be monitored for assigned protocols utilizing the Institutional Data and Safety Monitoring plan with limited guidance.
• Assist with development of documents and implementation of study-specific risk monitoring plans based on Institutional Data and Safety Monitoring Plan.
• Provide support around ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Minimum Education and/or Training:

• Bachelor's degree in relevant area required.

Minimum Experience:

Minimum Requirement: 2+ years of clinical research experience in a complex disease area (i.e. Oncology, Neuroscience, etc.)

• Prior clinical research monitoring experience preferred.

Special Skills, Knowledge and Abilities:

• Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.
• Adapts quickly to changing priorities to perform as needed in his/her role.
• Remains calm when faced with changes to (and in) his/her work.
• Effectively relays understanding of diverse perspectives.
• Can handle communication upwards and downwards as needed.
• Presents information in a clear, well thought out way and tailored to the audience.
• Shows support for the new direction even when the details have not been finalized.
• Spots early indications of underperformance and takes corrective actions. Celebrates successes.
• Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions.
• Supports creation/implementation of data management plans with understanding of site/study data sourcing techniques and overall compilation.
• Independently assists data management tasks/processes in line with study-related data plans.
• Identifies and resolves data queries and requirements based on knowledge of origin, flow, and management of data through a clinical study.
• Ensures compliance with SOPs related to data quality within assigned studies.
• Contributes to study management and research procedures by consistently executing on assigned tasks in compliance with GCP guidelines, with minimal supervision
• Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support).
• Shows awareness of basic safety, ethical, and HPP considerations, and regulatory requirements in terms of documentation and study conduct.
• Assists in development of relevant technical, study, and/or regulatory materials to ensure compliance with regulatory, safety, & ethical requirements.

Physical Demands and Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to stand; walk; sit; kneel, use hands to finger, handle, or feel; and talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, depth perception and the ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this