Job Description

Job Description

The Trial Documentation Associate II 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.

The Trial Documentation Associate II is responsible for supporting clinical trial activities as the regulatory document start-up and maintenance specialist. Responsible for ensuring clinical trial documents are collected and maintained according to Federal Regulations, ICH guidelines, appropriate project plans, IRB requirements, and applicable SOPs and guidelines. Supports the project manager (PM), Manager, Trial Documentation and Clinical Trials Operations management related to the project startup, maintenance, and close-out activities in specified administrative functions including electronic Trial Master File (eTMF) set-up and maintenance. Works closely with appropriate staff to help coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup. Serve as a point of contact for study teams/sites regarding regulatory documents, according to project management and monitor plans. Maintains communication regarding keeping site files current for the eTMF with Study Teams, CRMs and PMs. Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.

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 (e.g., protocols, informed consents, procedure manuals, eligibility checklists) as required.
• Review protocol and clinical trial documents to complete the OnCore patient calendar and create orders templates for protocol therapy builds in EPIC.
• Understand both research and clinical aspects of protocols to determine the number and design of orders templates and OnCore study calendars.
• 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.
• Trial Master File (TMF) experience preferred.
• Working knowledge of ICH/GCP guidelines preferred.
• Prior clinical research monitoring experience preferred.
• Prior medical writing experience preferred.
• SOCRA or ACRP certifications strongly 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 Trial Documentation Associate II.

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St. Jude is an Equal Opportunity Employer

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Job Tags

Permanent employment, Full time,

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