Clinical Research CTMS Calendar Build and Protocol Advisor

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A National Cancer Institute (NCI)-designated Comprehensive Cancer Center since 2001.

Summary

The Calendar Advisor serves as a subject-matter expert in clinical trial calendar development, applying advanced expertise in calendar building and protocol interpretation. This role requires strong clinical trial comprehension and in-depth protocol reading experience to advise on accurate, compliant calendar builds, provide oversight, and support ongoing calendar maintenance and quality for clinical studies.

Position Highlights

The Oncore Calendar Advisor will play a critical role in auditing and advising on calendar building, calendar maintenance, and Case Report Form (CRF) development within the Oncore Clinical Trials Management System (CTMS) for all clinical trials that meet Oncore entry criteria. Rather than performing these tasks directly, the Advisor will provide strategic oversight and expert guidance to ensure that all activities adhere to established quality standards and institutional requirements.

Key Responsibilities

Auditing and Advising

• Review and assess the development and implementation of research protocols within the Oncore CTMS.
• Provide expert consultation on calendar building and maintenance processes to ensure both accuracy and regulatory compliance.

Oversight and Guidance

• Deliver strategic guidance on the administration of Oncore, including the onboarding process and training for vendors.
• Ensure that all stakeholders are informed and equipped with the necessary knowledge to utilize the Oncore system effectively.

Quality Assurance

• Monitor the accuracy of calendars and CRF builds to guarantee they meet the center's quality requirement.
• Identify areas for improvement and provide actionable recommendations to enhance processes and outputs.

Collaboration

• Foster effective collaboration with Principal Investigators, Clinical Trial Business Office staff, Clinical Trial Office personnel, Research Finance teams, monitoring teams, and Biostatisticians.
• Address any issues related to calendar management and protocol implementation to ensure alignment across all parties involved.

Vendor Management

• Oversee vendor performance in relation to calendar-related functions, ensuring that they meet institutional standards and timelines.
• Facilitate communication between vendors and internal teams to streamline processes and resolve any challenges that may arise.

The Oncore Calendar Advisor will ensure that all calendar-related functions are executed efficiently and effectively, supporting the seamless operation of clinical trials and contributing to the overall success of research programs. By maintaining a focus on quality and collaboration, the Advisor will play an essential role in enhancing the research infrastructure and promoting best practices within the clinical trials landscape.

Credentials and Experience

• Bachelors Degree: Healthcare Administration, Finance, or other related field
• Requires minimum of three (3) years' experience as Clinical Trials Management System (CTMS) Calendar Builder at an academic institution
• In lieu of a Bachelor's degree, an Associate's degree and two (2) additional years' experience as Clinical Trials Management System (CTMS) Calendar Builder at an academic institution, total of five (5) years' experience will be considered.

Minimum Skills/Specialized Training Required

• Multitasking and Collaboration: Ability to effectively manage multiple tasks while working collaboratively with a diverse range of professionals, including physicians, biostatisticians, and finance staff.
• Oncore Expertise: Proven understanding of Oncore calendar building and protocol interpretation, ensuring accurate implementation and compliance.
• Deadline Management: Strong ability to perform well under pressure and consistently meet mandatory deadlines.
• CTMS Proficiency: Expertise in accurately building CTMS calendars and forms, serving as a resource for all Moffitt team members.
• Timely Deliverables: Demonstrated ability to deliver work products on time, exercising discretion to create high-quality outputs independently and holding vendors accountable for timely delivery.
• Clinical Trials Knowledge: In-depth understanding of clinical trial processes and research protocols.
• Training and Mentorship: Experience in training and mentoring staff or vendors, with a focus on best practices and compliance.
• Project Management: Strong organizational and project management skills, with the ability to manage multiple tasks and prioritize effectively.

Preferred Experience

• Oncology experience

Preferred Skills/Specialized Training

Technical Proficiency

• Proficiency in using Microsoft Office Suite and other relevant software tools for data management and reporting.