SR. CLINICAL RESEARCH COORDINATOR - HYBRID

Company: University Of California Irvine
Location: Orange
Posted on: November 11, 2024

Job Description:

Who We Are

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224-degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu. 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.Your Role on the Team

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 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).

• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships
• Ability to establish and maintain files and records
• Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• Access to transportation to off-site research locations
• 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
• Willingness to work as a supportive, cooperative member of an interdisciplinary team
• Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds
• Ability to independently exercise discretion and sound judgment
• Ability to interact with the public, faculty, and staff
• Skill in working independently, taking initiative and following through on assignments
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence.
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
• Ability to multitask and meet deadlines, despite interruptions
• Demonstrated ability to organize and prioritize a complex and dynamic workload
• 5 to 7 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
  What It Takes to be Successful
  
  Required:
  • 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.
    Special Conditions:
    • May require travel to satellite sites.
    • May require study management coordination outside of normal business hours. Total Compensation In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.
      Conditions of Employment: The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
      • Background Check and Live Scan
      • Legal Right to work in the United States
      • Vaccination Policies
      • Smoking and Tobacco Policy
      • Drug Free Environment The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
        • California Child Abuse and Neglect Reporting Act
        • E-Verify
        • Pre-Placement Health Evaluation Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php
          
          Closing Statement: The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.
          
          For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.
          
          For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.
          
          We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
          UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.Consideration for Work Authorization Sponsorship
          
          Must be able to provide proof of work authorization

Keywords: University Of California Irvine, Lakewood , SR. CLINICAL RESEARCH COORDINATOR - HYBRID, Healthcare , Orange, California