Sr. Protocol Review and Monitoring Coordinator - Hybrid

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.

Under the direction of the Protocol Review Manager, the Senior Protocol Review and Monitoring (SPRM) Coordinator is responsible for the coordination of Cancer Center committees including Disease Oriented Teams (DOTs), the Protocol Review and Monitoring Committee (PRMC), and the Data Safety and Monitoring Board (DSMB). The DOTs currently include, Neurological Oncology, Hematologic Malignancies, Gynecological, Genitourinary, Gastrointestinal, Pancreatic-Hepatobiliary, Skin, Thoracic, and Breast with additional DOTs initiated, as needed.

In addition to independently managing all aspects of committee operations, the Sr. PRM Coordinator has a leadership role in workflow optimization, cross-departmental process integration and training, compliance tracking, and strategic reporting. This individual serves as a resource and mentor to junior and entry level team members. Under the direction of the Protocol Review Manager, s/he will also lead regular training seminars to other Cancer Center staff (e.g. Regulatory Affairs Unit), demonstrating best practices and ensuring compliance with critical National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) requirements.

The Sr. PRM Coordinator is also responsible for advanced data analysis and reporting in OnCore and leads data quality improvement initiatives for the clinical trials committee review processes (e.g. ensuring compliance with CCSG data dictionary standards). Likewise, s/he will continue to maintain ongoing compliance and make recommendations on current review and documentation processes, policies, and procedures.

The incumbent is also responsible, under the direction of the Protocol Review Manager, for onboarding and training faculty and staff on Protocol Review and Monitoring System (PRMS) review processes as necessary.

The individual must accurately maintain clinical trial information in the clinical trial management system, OnCore, and adhere to both institutional policies and National Cancer Institute requirements.

Required:

• Experience coordinating operational logistics for high-level scientific and clinical meetings utilizing teleconference and web conference technology
• Demonstrated experience providing high level administrative support to faculty members
• Ability to draft clear, concise correspondence including editing, correct format and grammar, spelling and syntax for complex and scientific meetings
• Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• Demonstrated ability to make sound decisions and employ effective problem-solving techniques
• Ability to interact with the public, faculty, and staff.
• 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 maintain confidentiality of records and information
• Ability to compile 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 think critically and to compile and analyze data
• 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
• 5 to 7 Years of related work 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.
• Experience coordinating operational logistics for high-level scientific and clinical meetings utilizing teleconference and web conference technology.

Preferred:

• NCI Comprehensive Cancer Center committee administration experience
• Extensive experience 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:

• Requires coordinating some committee meetings outside of normal business hours along with travel back and forth to the Irvine and Orange campuses

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
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

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 is an Equal Opportunity Employer. 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 Anti-Discrimination Policy.

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.