Clinical Research Manager - Hybrid

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.

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.

Manages operations, including administrative and budget operations, for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives.

Required:

• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials.
• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities.
• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.
• Ability to analyze, plan and control budgets; effective management of multiple fund sources.
• Skills to manage complex research grants, contracts and sub-contracts-budget development, contract negotiation, appropriate reporting to required entities.
• Advanced degree in related area and / or equivalent experience / training
• Certificate in clinical research (CCRC) by ACRP or SOCRA
• 7- 9 years of experience
• Experience at a NCI-designated Comprehensive Cancer Center
• Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored

• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues.
• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.
• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.
• Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial.
• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.

In addition to the salary range listed below, we offer…