ASST. RESEARCH DATA COORDINATOR - HYBRID

University of California, Irvine•Orange, CA

7h•Hybrid

About The Position

Under the supervision of the Clinical Research Manager, the Assistant Research Data Coordinator (ARDC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive data management for a research portfolio of Phase I-IV cancer-related protocols. This role ensures adherence to Good Clinical Practices (GCP), internal standard operating procedures (SOPs), and University policies. The ARDC is responsible for the timely and accurate collection and submission of data to study sponsors, ensuring quality control and facilitating milestone payments. This includes compiling and transcribing research patient data and study-related information into case report forms (CRFs) and sponsor-specific electronic data capture systems (EDC). The incumbent will collaborate with the clinical research team, assist Principal Investigators and study coordinators with data management aspects of cancer-related trials, and serve as a liaison to sponsors, governing agencies, national cooperative oncology groups, and pharmaceutical companies. Additionally, the ARDC will maintain clinical trial information in the OnCore system and comply with institutional policies and 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 clearly and concisely, 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 a 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, compile 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.
Must be able to provide proof of work authorization.

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 (e.g., National Group, industrial, and Investigator-authored).

Responsibilities

Provide comprehensive data management for Phase I-IV cancer-related protocols.
Ensure timely and accurate collection and submission of data to study sponsors.
Compile and transcribe research patient data and study-related information into case report forms (CRFs) and electronic data capture systems (EDC).
Manage and collect accurate data in collaboration with the clinical research team.
Assist Principal Investigators and study coordinators with data management aspects of cancer-related trials.
Serve as a liaison to sponsors, governing agencies, national cooperative oncology groups, and pharmaceutical companies.
Maintain communication with all elements of a multi-level research network.
Interact with sponsoring agencies including the National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB) and Food and Drug Administration (FDA).
Accurately maintain clinical trial information in the clinical trial management system (OnCore).
Adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).