Research Data Coordinator - Hybrid

University of California, Irvine • Orange, CA

1d • Hybrid

About The Position

Under supervision of the Clinical Research Manager, the Research Data Coordinator (RDC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive data management for a research portfolio of Phase I-IV cancer-related protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.

The incumbent is responsible for supporting and coordinating all aspects of non-interventional cancer-related trials for protocol specific requirements, the timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments. This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor- specific electronic data capture systems (EDC). The incumbent will work with the clinical research team to manage and collect accurate data and assist Principal Investigators and study coordinators for all data management aspects of cancer-related trials.

Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

Requirements

• Working knowledge of medical terminology and accurately read progress notes in patient charts
• Ability to interact with the public, faculty, and staff
• Ability to establish and maintain files and records
• Willingness to work as a supportive, cooperative member of an interdisciplinary team
• Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence
• Demonstrated ability to organize and prioritize a complex and dynamic workload
• Ability to multitask and meet deadlines, despite interruptions
• Ability to independently exercise discretion and sound judgment
• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships
• Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds
• Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands
• Skill in working independently, taking initiative and following through on assignments
• Ability to think critically, compiles data from various sources, analyze data, and prepare reports.
• Ability to work both independently and as part of team
• Ability to take initiative and demonstrate strong commitment to duties
• Ability to analyze problems, implement solutions and multitask
• Ability to work within a deadline-driven structure
• Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
• High level of integrity and honesty in maintaining confidentiality
• Foster and promote a positive attitude and professional appearance
• Strong attention to detail
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• 3-5 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience

Nice To Haves

• Experience with cancer-related research.
• Knowledge with various types of human subject clinical trials i.e., National Group, industrial, and Investigator-authored.
• Experience with clinical trial management systems, preferably OnCore.

Responsibilities

• supporting and coordinating all aspects of non-interventional cancer-related trials for protocol specific requirements
• timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments
• compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor- specific electronic data capture systems (EDC)
• manage and collect accurate data and assist Principal Investigators and study coordinators for all data management aspects of cancer-related trials
• Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed
• maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors
• accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level