Updated: Mar 3, 2021 Location: UC Irvine Campus Job Type: Department: CANCER CENTER
Job Opening ID: 16030
Reports To: Clinical Research Manager
Working Title: Senior Clinical Research Coordinator
Department: Cancer Center
Bargaining Unit: RX
Payroll Job Code: 007888
Job Location: UCI Orange - Medical Center
Percent of Time: 100%
Work Schedule: 8-5, M-F
Employee Class: Career
Under the supervision of the Clinical Research Manager (CRM) within the Clinical Trials Unit, the Senior Clinical Research Coordinator (SCRC) supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management for complicated Phase I-IV cancer protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. The incumbent is responsible for supporting and coordinating all aspects of the cancer-related trials (Phase I-IV) for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedule appointments, etc. 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, including attending Disease Oriented Teams (DOTs) meetings, 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. The incumbent is responsible, under the direction of the CRM, to provide training and guidance to other clinical research coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service. The incumbent is responsible, under the direction of the CRM, for leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate ancillary medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial for the assigned disease area. 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).
5 to 7 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.
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.
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 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.
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 perform ongoing needs analysis and recommend solutions to resolve concerns.
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)
Experience with cancer-related research. Current nationally recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.) 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.
Special Conditions Required:
May require study management coordination outside of normal business hours. May require travel to satellite sites.
Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.