Clinical Research Coordinator

5 days ago

Irvine California, United States University of California, Irvine Full time
Job Summary

We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at the University of California, Irvine. The successful candidate will be responsible for coordinating clinical trials, managing data, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Coordinate clinical trials, including data collection, management, and submission to sponsors
  • Ensure timely and accurate data submission to study sponsors, maintaining quality control and leading to timely milestone payments
  • Compile and transcribe 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 non-cancer-related trials
  • Maintain communication with all elements of a multi-level research network, interacting with sponsoring agencies 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
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
  • Access to transportation to off-site research locations
  • 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, compile data from various sources, analyze data, and prepare reports
  • Ability to work both independently and as part of a 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)
Preferred Qualifications
  • Experience with clinical research and knowledge of various types of human subject clinical trials, i.e., National Group, Industrial, and Investigator-authored
  • Experience with clinical trial management systems, preferably OnCore
  • SoCRA or ACRP Certification

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