Sr. Clinical Research Coordinator - Hybrid

University of California, Irvine • Orange, CA

15d • Hybrid

About The Position

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 cancerprotocols 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 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).

Requirements

• 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, 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 concern.
• 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
• 5 to 7 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• 5 to 7 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.
• 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.

Responsibilities

• supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management for complicated Phase I-IV cancerprotocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
• 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.
• 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.
• 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.
• 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.
• 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