Study Data Coordinator I/II

University of Florida•Gainesville, FL

1d•Onsite

About The Position

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida's 16 colleges, pulling together a world-class, multi-disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure. As a Study Data Coordinator at the UF Health Cancer Institute (UFHCI), you will be responsible for ensuring the integrity, accuracy, and regulatory compliance of clinical research data across an assigned portfolio of oncology and hematology trials. Strong attention to detail, organization, and the ability to collaborate within a multidisciplinary clinical research environment is necessary for success in this role. In your new role you will be responsible for the following: Managing the data entry and integrity of collected research data and clinical information for an assigned portfolio of human clinical trials. This will include a variety of data management focused tasks such as data abstraction and entry, reporting, and query resolution, all of which require regular and timely communication with Study Coordinators, investigators, other CRO staff, and the subjects themselves, as well as minute attention to detail throughout the conduct of the trial. Verification and review of medical and clinical data of potential and existing subjects as assigned clinical trials. It is of the utmost importance that you confirm and document accurate study in accordance with study guidelines and timelines and protect subject privacy in compliance with relevant privacy laws. Maintaining and ensuring compliance with all internal and external regulatory and institutional requirements related to your trials. You will also attend all relevant trainings and meetings including Tumor Boards, monthly educational topics, etc. as required, and provide in-service education related to assigned protocols to ensure study compliance. Coordination and management of study audits and QA activities related to your assigned portfolio, serving as the primary point of contact for internal and external auditors to resolve data queries and provide reports as requested and necessary. This is an entry to experienced level position, ideal for candidates with foundational to intermediate experience in clinical research, data management, or healthcare-related fields who are seeking to grow in a collaborative research environment. Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.

Requirements

Relevant experience and/or training in clinical research, data management, or oncology
Strong attention to detail with experience working with clinical databases and subject data
Proficiency in Microsoft Office (Outlook, Excel, Word) and ability to interpret clinical/research data
Ability to manage priorities, meet deadlines, and communicate effectively in a fast-paced environment
Professional clinical research certification (SOCRA or ACRP) required within 12 months of hire or eligibility
Experience managing clinical research data or supporting complex research protocols
Exceptional attention to detail with experience working with clinical databases and subject data
Proficiency in Microsoft Office (Outlook, Excel, Word) and ability to interpret and validate complex clinical data
Ability to manage multiple priorities, meet deadlines, and communicate effectively across multidisciplinary teams

Nice To Haves

Bachelor’s degree in Health Care, Basic Sciences, or a related field and three to four years of relevant experience and/or training in clinical research and/or oncology
Experience supporting clinical trials or research data management in an academic or healthcare setting
Strong interpersonal and relationship-building skills across multidisciplinary teams
Adaptable and resourceful with the ability to work independently and collaboratively
Demonstrated professionalism, emotional intelligence, and sound judgment
Experience with clinical data systems or electronic data capture platforms
Strong written documentation skills and ability to manage competing priorities
Project management mindset with skills in organization, critical thinking, and process improvement
Bachelor’s degree in Health Care, Basic Sciences, or a related field with four to six years of relevant experience and/or training in clinical research and/or oncology
Experience managing higher complexity clinical trials or research portfolios
Experience working in an academic medical center or similar research environment
Strong interpersonal and relationship-building skills across diverse stakeholders
Highly resourceful, adaptable, and able to work independently with sound judgment
Demonstrated professionalism, emotional intelligence, and customer service orientation
Experience with clinical data systems or electronic data capture platforms
Strong written communication and documentation skills
Project management mindset with skills in organization, critical thinking, and process improvement

Responsibilities

Managing the data entry and integrity of collected research data and clinical information for an assigned portfolio of human clinical trials. This will include a variety of data management focused tasks such as data abstraction and entry, reporting, and query resolution, all of which require regular and timely communication with Study Coordinators, investigators, other CRO staff, and the subjects themselves, as well as minute attention to detail throughout the conduct of the trial.
Verification and review of medical and clinical data of potential and existing subjects as assigned clinical trials. It is of the utmost importance that you confirm and document accurate study in accordance with study guidelines and timelines and protect subject privacy in compliance with relevant privacy laws.
Maintaining and ensuring compliance with all internal and external regulatory and institutional requirements related to your trials. You will also attend all relevant trainings and meetings including Tumor Boards, monthly educational topics, etc. as required, and provide in-service education related to assigned protocols to ensure study compliance.
Coordination and management of study audits and QA activities related to your assigned portfolio, serving as the primary point of contact for internal and external auditors to resolve data queries and provide reports as requested and necessary.