Operations Director, Clinical Research Services- Cancer Center
BASIC FUNCTION AND RESPONSIBILITY
Responsible for the execution of high impact clinical research in oncology to include 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 the 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 the oversight of data management, financial pre-study budget preparation and negotiation, study billing, coordinator oversight, and regulatory and compliance activities. The Administrative Director serves as the partner for the CPDM Medical Director and Associate Director for Clinical Research to compile, write and present information for 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 the provider and physician leadership, nursing leadership, and staff of the clinical cancer center, insuring patient access to cutting edge treatments and supportive oncology clinical services.
CHARACTERISTIC DUTIES AND 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 Food and Drug Administration (FDA), Good Clinical Practice (GCP) guidelines, Data Safety and Monitoring Committee (DSMC), Protocol Review and Monitoring Committee (PRMC), University of Iowa Regulatory Board (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 patients 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 the onboarding of new clinical research faculty offering orientation, training, and specialized education sessions as needed.
· Explore the potential for clinical trials collaborations outside the University of Iowa with the 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.
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UI Health Care Core Values (WE CARE) |
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Welcoming |
We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people. |
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Excellence |
We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research. |
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Collaboration |
We collaborate with health care systems, providers, and communities across Iowa and the region as well within our UI community. We believe teamwork- guided by compassion- is the best way to work. |
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Accountability |
We behave ethically, act openly and with integrity in all that we do, taking responsibility for our actions. |
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Respect |
We create an environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community. |
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Empowerment |
We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners. |
University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®
Holden Comprehensive Cancer Center is Iowa’s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as University of Iowa Health Care and Children’s Hospital.
SUPERVISION RECEIVED:
The Operations Director for Clinical Research Services reports to the HCCC Associate Director for Administration. Collaborates extensively 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 manager in clinical coordination, finance, regulatory and compliance and data analysis, and (~140) staff in the Holden Comprehensive Cancer Center’s Clinical Research Services.
Percent of Time: 100%
Pay Grade: 6A
https://hr.uiowa.edu/pay/guide-pay-plans
Benefits Highlights:
- 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
- For more information about Why Iowa?, click here
REQUIRED QUALIFICATIONS
- Master’s 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 5-7 years of directly related clinical research administrative experience including a minimum of 3 years personnel and fiscal management experience.
- Professional job-related experience fostering or promoting a welcoming and respectful work/academic environment; or demonstrated ability to do so.
- Excellent leadership, team building, collaboration, and communication (written, verbal, and interpersonal) skills.
- Demonstrated knowledge of drug development process.
- Demonstrated knowledge of research regulations and sponsor operating procedures.
- Knowledge of and experience with contract and grant application processes.
- Knowledge of and experience with oncology related programs.
- Demonstrated 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.
- Demonstrated ability to communicate effectively with physicians, researchers, administrators, and supervisors.
- Previous administrative experience in a matrix organization.
DESIRABLE QUALIFICATIONS
- Experience with Oncore or a similar Clinical Trials Management System.
- Experience with EPIC and Beacon plans as an enterprise wide electronic health record.
- Previous administrative experience in a large health care organization.
- Previous administrative experience in an academic cancer center.
- Previous experience developing and managing an early phase clinical research program.
Application Process: In order to be considered, applicants must upload a resume and cover letter (under submission relevant materials) 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.
With additional questions, please reach out to Anne Pitkin at anne-pitkin@uiowa.edu
Equal opportunity/affirmative action employer
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
