Director of Clinical Research Administration & Finance

About the role

The UCI Center for Clinical Research (CCR) is a full-service clinical trials unit serving a diverse array of clinical trials across 20 clinical departments, alongside the Stern Center for Clinical Trials and Cancer Research (cancer clinical trials) and the Alpha Clinic (cell and gene therapies). CCR is a large unit (approximately 70 staff), including clinical research coordinators, regulatory affairs, finance, and administrative positions. This unit is responsible for end-to-end coordination of interventional clinical trials and provides service support for non-interventional/minimal risk clinical trials across UCI's medical centers, clinics, and satellite sites in the Orange County region.

Responsibilities

• Directly responsible for all administrative operations encompassed within the UCI Center for Clinical Research.
• Develops short and long-range planning of administrative and financial goals and objectives regarding this clinical trials unit, including strategic support initiatives and other special projects.
• Serves in an advisory capacity to the Medical Director on all matters related to the UCI Center for Clinical Research’s three main divisions: clinical operations, finance, and business development and technology.
• Serves as the main point of contact to other departments, the School of Medicine Dean’s Office, Medical Center Offices as well as other campus offices and organizations and as administrative liaison for affiliated hospitals and external agencies.

Requirements

• 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.
• 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.
• 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.
• 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.
• Innovative decision-making and judgment on a frequent basis entailing the planning, development and implementation of new policies, procedures and situation solutions regarding cancer clinical research.
• Experience working in a multidisciplinary matrixed work environment.
• Advanced degree in related area and / or equivalent experience / training.
• Research certification (ACRP, SoCRA, or equivalent).
• 10+ years of relevant work experience with a Bachelor degree in related field, 5-7 years of relevant work experience with a Masters degree, or equivalent experience.
• 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.
• Experience with the campus' clinical and research information and documentation application programs.
• Technical proficiency in project management software.

Qualifications

• Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• 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.
• 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.
• 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.
• Innovative decision-making and judgment on a frequent basis entailing the planning, development and implementation of new policies, procedures and situation solutions regarding cancer clinical research.
• Experience working in a multidisciplinary matrixed work environment.
• Advanced degree in related area and / or equivalent experience / training.
• Research certification (ACRP, SoCRA, or equivalent).
• 10+ years of relevant work experience with a Bachelor degree in related field, 5-7 years of relevant work experience with a Masters degree, or equivalent experience.
• 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.
• Experience with the campus' clinical and research information and documentation application programs.
• Technical proficiency in project management software.

Skills

• Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• 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.
• 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.
• 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.
• Innovative decision-making and judgment on a frequent basis entailing the planning, development and implementation of new policies, procedures and situation solutions regarding cancer clinical research.
• Experience working in a multidisciplinary matrixed work environment.
• Advanced degree in related area and / or equivalent experience / training.
• Research certification (ACRP, SoCRA, or equivalent).
• 10+ years of relevant work experience with a Bachelor degree in related field, 5-7 years of relevant work experience with a Masters degree, or equivalent experience.
• 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.
• Experience with the campus' clinical and research information and documentation application programs.
• Technical proficiency in project management software.

Benefits

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Pay

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Schedule

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Contact Information

For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.