Administrative Director, Clinical Research Operations in Irvine, CA for University of California, Irvine (UCI)

University of California Irvine

Administrative Director, Clinical Research Operations

Updated: Nov 24, 2021
Location: UC Irvine Campus
Job Type:
Department: Cancer Center

Job Opening ID: 27597

Reports To: Academic Program Manager 2

Working Title: Administrative Director, Clinical Research Operations

Department: Cancer Center

Bargaining Unit: 99

FLSA: Exempt

Payroll Job Code: 006571

Job Location: UCI Campus- Irvine

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class: Career

Position Summary:

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. CFCCC Clinical Research Operations is a centralized resource to facilitate the development, conduct, quality assurance monitoring, compliance with regulatory agency requirements, and monitoring of cancer-relevant clinical research. Responsible for the strategic planning, organizing and oversight of operations and resource management for the CFCCC clinical research enterprise, including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement. The AD-CRO is responsible for ensuring and maintaining an appropriate clinical research infrastructure and ensures that all institutional, local, state, and federal regulations, including good clinical practice requirements are met. The AD-CRO works directly with the CAO, Associate Director for Clinical Science (Medical Director), and the Center Director, in defining and prioritizing specific needs related to the Center's clinical research mission and in developing objectives and strategies to meet those needs. Manage and oversee clinical research coordination, budget development, administration of the Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC) and the Data and Safety Monitoring Committee (DSMC), quality assurance for investigator-initiated studies, regulatory affairs support services, IND submissions, and ongoing data management. The AD-CRO will be responsible for tracking the overall protocol activation timeline and working with the CAO and Associate Director for Clinical Science toward efficiency and improvement wherever possible and/or necessary. Serve as a subject matter expert on clinical research-related segments of the National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) Guidelines (e.g. Clinical Protocol and Data Management and Protocol Review and Monitoring System) and works closely with the CAO to provide guidance and recommendations to CFCCC senior leadership. The AD-CRO will have primary responsibility for the direction and leadership for development of the clinical researchrelated segments of the CCSG grant submission and will have management responsibility for the ongoing development and maintenance of all Standard Operating Procedures (SOPs) related to clinical research operations. Work in partnership with the School of Medicine Office of Research Support Services to coordinate industry budget negotiation, prompt development of coverage analysis and study calendars, and accurate and efficient shared oversight of technology support operations and data coordination and reporting with a focus on ongoing establishment of a rapid-response infrastructure and streamlined workflow. The AD-CRO oversees consistent and logical coding and data entry for all cancer-relevant studies into the clinical trials management system in accordance with NCI CCSG guidelines, internal and external regulations of other agencies and overall best business practices. The AD-CRO has senior management oversight over trial accrual data, including any satellite and/or affiliate institutions, as required by the NCI.

Responsible for all matters pertaining to the administration of clinical research operations for the Chao Family Comprehensive Cancer Center. The principal role is to support the Chief Administrative Officer and Cancer Center Director in fulfilling the clinical research mission of the Chao Family Comprehensive Cancer Center, the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. Manages administrative operations for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives.

Compensation Range:

$86,900.00 - $136,200.00

Department Website:

http://www.cancer.uci.edu/

Required:

10+ years of relevant work experience with a Bachelor of Arts/Bachelor of Science in related field, 5-7 years of relevant work experience with a Masters of Arts/Masters of Science, or equivalent experience.

Master's degree in related area and / or equivalent experience / training.

Advanced practice nursing certifications, particularly in Public Health, Emergency Nursing and Basic Life Support.

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.

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.

Preferred:

Registered Nurse preferred.

Experience with the campus' clinical and research information and documentation application programs. Technical proficiency in project management software Familiarity and knowledge with Cancer Center Support Grant guidelines. Experience working in a multidisciplinary matrixed work environment.

Special Conditions Required:

Travel to Irvine campus and satellite work sites as needed

Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination policy.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.

Job Opening ID: 27597Reports To: Academic Program Manager 2Working Title: Administrative Director, Clinical Research OperationsDepartment: Cancer CenterBargaining Unit: 99FLSA: ExemptPayroll Job Code: 006571Job Location: UCI Campus- IrvinePercent of Time: 100%Work Schedule: 8-5, M-FEmployee Class: Career Position Summary: 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. CFCCC Clinical Research Operations is a centralized resource to facilitate the development, conduct, quality assurance monitoring, compliance with regulatory agency requirements, and monitoring of cancer-relevant clinical research. Responsible for the strategic planning, organizing and oversight of operations and resource management for the CFCCC clinical research enterprise, including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement. The AD-CRO is responsible for ensuring and maintaining an appropriate clinical research infrastructure and ensures that all institutional, local, state, and federal regulations, including good clinical practice requirements are met. The AD-CRO works directly with the CAO, Associate Director for Clinical Science (Medical Director), and the Center Director, in defining and prioritizing specific needs related to the Center's clinical research mission and in developing objectives and strategies to meet those needs. Manage and oversee clinical research coordination, budget development, administration of the Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC) and the Data and Safety Monitoring Committee (DSMC), quality assurance for investigator-initiated studies, regulatory affairs support services, IND submissions, and ongoing data management. The AD-CRO will be responsible for tracking the overall protocol activation timeline and working with the CAO and Associate Director for Clinical Science toward efficiency and improvement wherever possible and/or necessary. Serve as a subject matter expert on clinical research-related segments of the National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) Guidelines (e.g. Clinical Protocol and Data Management and Protocol Review and Monitoring System) and works closely with the CAO to provide guidance and recommendations to CFCCC senior leadership. The AD-CRO will have primary responsibility for the direction and leadership for development of the clinical researchrelated segments of the CCSG grant submission and will have management responsibility for the ongoing development and maintenance of all Standard Operating Procedures (SOPs) related to clinical research operations. Work in partnership with the School of Medicine Office of Research Support Services to coordinate industry budget negotiation, prompt development of coverage analysis and study calendars, and accurate and efficient shared oversight of technology support operations and data coordination and reporting with a focus on ongoing establishment of a rapid-response infrastructure and streamlined workflow. The AD-CRO oversees consistent and logical coding and data entry for all cancer-relevant studies into the clinical trials management system in accordance with NCI CCSG guidelines, internal and external regulations of other agencies and overall best business practices. The AD-CRO has senior management oversight over trial accrual data, including any satellite and/or affiliate institutions, as required by the NCI. Responsible for all matters pertaining to the administration of clinical research operations for the Chao Family Comprehensive Cancer Center. The principal role is to support the Chief Administrative Officer and Cancer Center Director in fulfilling the clinical research mission of the Chao Family Comprehensive Cancer Center, the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. Manages administrative operations for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives. Compensation Range: $86,900.00 - $136,200.00 Department Website: http://www.cancer.uci.edu/
Required: 10+ years of relevant work experience with a Bachelor of Arts/Bachelor of Science in related field, 5-7 years of relevant work experience with a Masters of Arts/Masters of Science, or equivalent experience.Master's degree in related area and / or equivalent experience / training.Advanced practice nursing certifications, particularly in Public Health, Emergency Nursing and Basic Life Support.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.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. Preferred: Registered Nurse preferred.Experience with the campus' clinical and research information and documentation application programs. Technical proficiency in project management software Familiarity and knowledge with Cancer Center Support Grant guidelines. Experience working in a multidisciplinary matrixed work environment. Special Conditions Required: Travel to Irvine campus and satellite work sites as needed Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination policy.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.

To apply, visit https://careersucirvine.ttcportals.com/jobs/8041338-administrative-director-clinical-research-operations

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