ASST. RESEARCH DATA COORDINATOR - HYBRID

University of California, Irvine•Orange, CA

4d•$27 - $34•Hybrid

About The Position

Under supervision of the Clinical Research Manager, the Assistant Research Data Coordinator (ARDC) supports the clinical research efforts of the CFCCC 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 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). S/he 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

Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
Ability to independently exercise discretion and sound judgment
Ability to take initiative and demonstrate strong commitment to duties
Access to transportation to off-site research locations
Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence
Ability to interact with the public, faculty, and staff
Willingness to work as a supportive, cooperative member of an interdisciplinary team
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 work both independently and as part of team
Foster and promote a positive attitude and professional appearance
Ability to establish and maintain files and records
Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint
Ability to think critically, compiles data from various sources, analyze data, and prepare reports.
Ability to analyze problems, implement solutions and multitask
Strong attention to detail
Working knowledge of medical terminology and accurately read progress notes in patient charts
High level of integrity and honesty in maintaining confidentiality
Demonstrated ability to organize and prioritize a complex and dynamic workload
Ability to multitask and meet deadlines, despite interruptions
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 work within a deadline-driven structure
Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
1-3 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience

Nice To Haves

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

Responsibilities

Responsible for the 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).
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.
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.
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).

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