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.

UI Health Care Core Values (WE CARE)

Welcoming

We are welcoming to the community partners staff and patients utilizing the collective strength of our people.

Excellence

We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care education and research.

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.

Accountability

We behave ethically act openly and with integrity in all that we do taking responsibility for our actions.

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.

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 Carerecognized as one of the best hospitals in the United Statesis Iowas only comprehensive academic medical center and a regional referral center. Each day more than 12000 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 Iowas 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 Childrens 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 Centers Clinical Research Services.

Percent of Time: 100%

Pay Grade:6A

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
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