Clinical Research Monitor

Freddie Mac; United States; Remote; USD 70,000 - 127,000; Full time

Job summary

A leading company is seeking a Clinical Research Monitor to support clinical research studies by ensuring compliance, managing documentation, and auditing materials. The successful candidate will have a bachelor's degree and at least 2 years of experience in clinical research, particularly in complex disease areas like Oncology or Neuroscience. This role involves travel and working closely with study teams to ensure successful project execution.

Benefits

Exceptional benefits

Qualifications

• 2+ years of clinical research experience in a complex disease area.
• Experience managing clinical trial regulatory documents.
• Preferred past experience in clinical research monitoring and medical writing.

Responsibilities

• Monitor protocol and regulatory compliance of clinical research studies.
• Review research data for accuracy and completeness.
• Write detailed monitoring reports and maintain essential documents.

Skills

Analytical skills

Attention to detail

Communication

Education

Bachelor's degree in relevant area

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.

Travel required for assigned studies.

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.
• 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 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.

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St. Jude is an Equal Opportunity Employer

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