The University Of Iowa
Operations Director, Clinical Research Services- Cancer Center
The University Of Iowa, Iowa City, Iowa, United States, 52245
Overview
Operations Director, Clinical Research Services Cancer Center is responsible for the execution of high?impact clinical research in oncology, including federally funded, foundation, consortium, industry?sponsored, and investigator?initiated human subject research. Provides operational oversight for Clinical Research Services including short and long?term strategic planning, fiscal oversight, leadership, policy development and implementation, regulatory compliance, resource management, design and development of operational and financial programs, space and facility management, and personnel administration for the clinical research operations in Holden Comprehensive Cancer Center (HCCC), an NCI?designated Comprehensive Cancer Center. This role provides day?to?day leadership, supervision, and coordination for clinical research operations including oversight of data management, pre?study budget preparation and negotiation, study billing, coordinator oversight, and regulatory and compliance activities. The Administrative Director partners with the CPDM Medical Director and Associate Director for Clinical Research to compile, write and present information for the NCI Cancer Center Support Grant. This leader collaborates with teams implementing modules and refining data capture in the data management system (Oncore), cooperative groups reporting, compliance and billing, and implementation of investigator?initiated trials (IITs). This role works collaboratively with provider and physician leadership, nursing leadership, and staff of the clinical cancer center, ensuring patient access to cutting edge treatments and supportive oncology clinical services. Responsibilities
Direct, oversee, and ensure compliance of all regulatory, financial, administrative, clinical coordination, and operational activities within the HCCC Clinical Research Services. Ensure clinical research is conducted within applicable regulatory requirements of the FDA, Good Clinical Practice (GCP) guidelines, Data Safety and Monitoring Committee (DSMC), Protocol Review and Monitoring Committee (PRMC), University of Iowa IRB, WIRB, Quorum, NCI CIRB, and all applicable IRBs. Develop, implement, and manage standard operating procedures that achieve integration and seamless operations of the HCCC clinical research. Evaluate work requirements for all clinical research components and implement change as necessary, based on current research activity and staffing needs in consultation with medical leadership. Align clinical research services with clinical services to ensure high quality patient care in an efficient system of care delivery. Collaboratively develop and implement a strategic plan for clinical research operations that supports patient access to clinical care and trials involving new treatment modalities in a manner that enhances patient, staff and provider experience. Enhance opportunities for clinical research throughout network sites in Iowa. Encourage the recruitment of all eligible patients to clinical trials. Further build an early phase clinical research program with cohesive infrastructure and rapid, responsive systems for trial opening. Review, create, and monitor policies related to the financial management of clinical research; monitor related emerging federal, state, and local policies pertaining to clinical trial financial management. Prepare annual operations budget for clinical research; project future revenue and expenses based upon analysis of current operations. Optimize Oncore database for data collection and retrieval to support clinical research operations. Collaborate with the Oncore data team for reporting for the Cancer Center Support Grant (P30), including summaries on accrual of therapeutic and non?therapeutic trials at all sites, by trial sponsor and population cohorts. Participate in institutional, state, and national committees and consortia related to clinical research operations. Responsible for staff evaluations, training, continuing education, and career development. Assist with onboarding of new clinical research faculty offering orientation, training, and specialized education sessions as needed. Explore potential for clinical trials collaborations outside the University of Iowa with physician leadership of HCCC clinical research activities and the Associate Director for Administration. Serve as liaison and consultant to HCCC Administration, Principal Investigators, researchers, physicians, staff, and others relative to clinical research activities. Establish and maintain cooperative working relationships with colleagues, faculty, and staff. Evaluate processes, identify resources, training, and educational needs and facilitate resolutions. Analyze areas of research interest to identify potential clinical protocol development and opportunities. UI Health Care Core Values
WE CARE: Welcoming, Accountability, Respect, and Empowerment. We are welcoming to the community, partners, staff, and patients; we act with integrity and accountability; we create an environment where all individuals feel safe, valued, and respected; we commit to fair access to research, health care, and education for our community and opportunities for growth for staff and learners. University of Iowa Health Care is an equal opportunity employer and Holden Comprehensive Cancer Center coordinates cancer?related research, education, and patient care across multiple departments and colleges. SUPERVISION RECEIVED
The Operations Director for Clinical Research Services reports to the HCCC Associate Director for Administration and collaborates with the Medical Director for Clinical Protocol Development and Management and the Associate Director for Clinical Research. SUPERVISION EXERCISED
Direct administrative and functional supervision is exercised over managers in clinical coordination, finance, regulatory and compliance, and data analysis, and approximately 140 staff in the Holden Comprehensive Cancer Centers Clinical Research Services. Benefits and Conditions
Regular salaried position located in Iowa City, Iowa Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans REQUIRED QUALIFICATIONS
Masters degree in business, finance, science, or another related field, or an equivalent combination of education and experience. Society of Clinical Research Associates (SoCRA) certification required within 12 months of hire. Minimum of 57 years of directly related clinical research administrative experience including a minimum of 3 years personnel and fiscal management experience. Professional experience fostering a welcoming and respectful work/academic environment; or demonstrated ability to do so. Excellent leadership, team building, collaboration, and communication skills. Demonstrated knowledge of the drug development process. Knowledge of research regulations and sponsor operating procedures. Knowledge of contract and grant application processes. Knowledge of oncology programs. Ability to build and foster a culture of service, collaboration, and accountability. Experience in business/program development. Knowledge of clinical research billing practices, financial analysis, and reporting. Ability to communicate effectively with physicians, researchers, administrators, and supervisors. Previous administrative experience in a matrix organization. DESIRABLE QUALIFICATIONS
Experience with Oncore or similar Clinical Trials Management System. Experience with EPIC and Beacon as an enterprise EHR plan. Administrative experience in a large health care organization. Administrative experience in an academic cancer center. Experience developing and managing an early phase clinical research program. Application Process
To be considered, applicants must upload a resume and cover letter that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Successful candidates will be required to self?disclose any conviction history and will be subject to a criminal background check and credential/education verification. References: Five professional references will be requested and required at a later step in the recruitment process. This position is not eligible for University sponsorship for employment authorization. Equal Opportunity
The University of Iowa Health Care is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy, disability, genetic information, veteran status, sexual orientation, or associational preferences. Persons with disabilities who need assistance or accommodations may contact University Human Resources/Faculty and Staff Disability Services. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration. #J-18808-Ljbffr
Operations Director, Clinical Research Services Cancer Center is responsible for the execution of high?impact clinical research in oncology, including federally funded, foundation, consortium, industry?sponsored, and investigator?initiated human subject research. Provides operational oversight for Clinical Research Services including short and long?term strategic planning, fiscal oversight, leadership, policy development and implementation, regulatory compliance, resource management, design and development of operational and financial programs, space and facility management, and personnel administration for the clinical research operations in Holden Comprehensive Cancer Center (HCCC), an NCI?designated Comprehensive Cancer Center. This role provides day?to?day leadership, supervision, and coordination for clinical research operations including oversight of data management, pre?study budget preparation and negotiation, study billing, coordinator oversight, and regulatory and compliance activities. The Administrative Director partners with the CPDM Medical Director and Associate Director for Clinical Research to compile, write and present information for the NCI Cancer Center Support Grant. This leader collaborates with teams implementing modules and refining data capture in the data management system (Oncore), cooperative groups reporting, compliance and billing, and implementation of investigator?initiated trials (IITs). This role works collaboratively with provider and physician leadership, nursing leadership, and staff of the clinical cancer center, ensuring patient access to cutting edge treatments and supportive oncology clinical services. Responsibilities
Direct, oversee, and ensure compliance of all regulatory, financial, administrative, clinical coordination, and operational activities within the HCCC Clinical Research Services. Ensure clinical research is conducted within applicable regulatory requirements of the FDA, Good Clinical Practice (GCP) guidelines, Data Safety and Monitoring Committee (DSMC), Protocol Review and Monitoring Committee (PRMC), University of Iowa IRB, WIRB, Quorum, NCI CIRB, and all applicable IRBs. Develop, implement, and manage standard operating procedures that achieve integration and seamless operations of the HCCC clinical research. Evaluate work requirements for all clinical research components and implement change as necessary, based on current research activity and staffing needs in consultation with medical leadership. Align clinical research services with clinical services to ensure high quality patient care in an efficient system of care delivery. Collaboratively develop and implement a strategic plan for clinical research operations that supports patient access to clinical care and trials involving new treatment modalities in a manner that enhances patient, staff and provider experience. Enhance opportunities for clinical research throughout network sites in Iowa. Encourage the recruitment of all eligible patients to clinical trials. Further build an early phase clinical research program with cohesive infrastructure and rapid, responsive systems for trial opening. Review, create, and monitor policies related to the financial management of clinical research; monitor related emerging federal, state, and local policies pertaining to clinical trial financial management. Prepare annual operations budget for clinical research; project future revenue and expenses based upon analysis of current operations. Optimize Oncore database for data collection and retrieval to support clinical research operations. Collaborate with the Oncore data team for reporting for the Cancer Center Support Grant (P30), including summaries on accrual of therapeutic and non?therapeutic trials at all sites, by trial sponsor and population cohorts. Participate in institutional, state, and national committees and consortia related to clinical research operations. Responsible for staff evaluations, training, continuing education, and career development. Assist with onboarding of new clinical research faculty offering orientation, training, and specialized education sessions as needed. Explore potential for clinical trials collaborations outside the University of Iowa with physician leadership of HCCC clinical research activities and the Associate Director for Administration. Serve as liaison and consultant to HCCC Administration, Principal Investigators, researchers, physicians, staff, and others relative to clinical research activities. Establish and maintain cooperative working relationships with colleagues, faculty, and staff. Evaluate processes, identify resources, training, and educational needs and facilitate resolutions. Analyze areas of research interest to identify potential clinical protocol development and opportunities. UI Health Care Core Values
WE CARE: Welcoming, Accountability, Respect, and Empowerment. We are welcoming to the community, partners, staff, and patients; we act with integrity and accountability; we create an environment where all individuals feel safe, valued, and respected; we commit to fair access to research, health care, and education for our community and opportunities for growth for staff and learners. University of Iowa Health Care is an equal opportunity employer and Holden Comprehensive Cancer Center coordinates cancer?related research, education, and patient care across multiple departments and colleges. SUPERVISION RECEIVED
The Operations Director for Clinical Research Services reports to the HCCC Associate Director for Administration and collaborates with the Medical Director for Clinical Protocol Development and Management and the Associate Director for Clinical Research. SUPERVISION EXERCISED
Direct administrative and functional supervision is exercised over managers in clinical coordination, finance, regulatory and compliance, and data analysis, and approximately 140 staff in the Holden Comprehensive Cancer Centers Clinical Research Services. Benefits and Conditions
Regular salaried position located in Iowa City, Iowa Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans REQUIRED QUALIFICATIONS
Masters degree in business, finance, science, or another related field, or an equivalent combination of education and experience. Society of Clinical Research Associates (SoCRA) certification required within 12 months of hire. Minimum of 57 years of directly related clinical research administrative experience including a minimum of 3 years personnel and fiscal management experience. Professional experience fostering a welcoming and respectful work/academic environment; or demonstrated ability to do so. Excellent leadership, team building, collaboration, and communication skills. Demonstrated knowledge of the drug development process. Knowledge of research regulations and sponsor operating procedures. Knowledge of contract and grant application processes. Knowledge of oncology programs. Ability to build and foster a culture of service, collaboration, and accountability. Experience in business/program development. Knowledge of clinical research billing practices, financial analysis, and reporting. Ability to communicate effectively with physicians, researchers, administrators, and supervisors. Previous administrative experience in a matrix organization. DESIRABLE QUALIFICATIONS
Experience with Oncore or similar Clinical Trials Management System. Experience with EPIC and Beacon as an enterprise EHR plan. Administrative experience in a large health care organization. Administrative experience in an academic cancer center. Experience developing and managing an early phase clinical research program. Application Process
To be considered, applicants must upload a resume and cover letter that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Successful candidates will be required to self?disclose any conviction history and will be subject to a criminal background check and credential/education verification. References: Five professional references will be requested and required at a later step in the recruitment process. This position is not eligible for University sponsorship for employment authorization. Equal Opportunity
The University of Iowa Health Care is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy, disability, genetic information, veteran status, sexual orientation, or associational preferences. Persons with disabilities who need assistance or accommodations may contact University Human Resources/Faculty and Staff Disability Services. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration. #J-18808-Ljbffr