Offer summary

Qualifications:

Bachelor's degree in a relevant area required., 2+ years of clinical research experience in a complex disease area such as Oncology or Neuroscience., Prior experience managing clinical trial regulatory documents is necessary., Preferred experience in clinical research monitoring and medical writing..

Key responsabilities:

Monitor protocol and regulatory compliance of clinical research studies across multiple treatment areas.

Review research data for accuracy, completeness, and timeliness using Electronic Data Capture systems.

Track and manage documentation, study status, and key milestones within various systems.

Write detailed monitoring reports and assist in developing study-specific risk monitoring plans.

Job description

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.

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.
Develop study-related documents as required.
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 experience managing flow of clinical trial regulatory documents.
Prior clinical research monitoring experience preferred.
Prior medical writing experience preferred.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $70,720 - $126,880 per year for the role of Clinical Research Monitor.

Explore our exceptional benefits!

St. Jude is an Equal Opportunity Employer

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