RN Supv, Clinical Research Ops
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Position Summary
This position provides supervisory guidance to research nurses and coordinators in assigned departments to ensure efficient operations with regards to work productivity and results, employee performance, quality assurance, and patient safety/satisfaction. This position also serves the functions of a Senior Clinical Research Nurse for specific clinical trials at all phases of development. This position requires strong nursing knowledge/skills, advanced-level clinical research knowledge/skills, and will be responsible for mentoring and training research nurses, coordinators, and assistants in the designated areas. This position works independently in performing nursing duties required for research protocols and performing all required duties from study start-up through study closure (creation of study budget/coverage analysis, acquisition/processing of specimens, maintenance of regulatory/administrative compliance, extraction/entry of data, completion of patient visits per protocol requirements, and maintenance of compliant billing procedures). This position will support staff in completion of department related study budgets/coverage analysis as well as maintain departmental adherence to billing requirements.
Position Duties
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Supervises research nurses, coordinators, and assistants in assigned area(s).
1. Plans and organizes the daily operations of the assigned area(s). Ensures efficiency of department’s operations; develops quality standards and monitors and maintains quality of staff performance in accordance with research and internal regulations and policies.
2. Oversees and coordinates the scheduling and efficient usage of resources and participates in the development of operating goals and objectives for the assigned area(s). Recommends, implements, and administers methods and procedures to enhance operations as appropriate to the department.
3. Coordinates orientation and training for new clinical research staff. Assists with the identification of staff community learning needs; administers training where needed.
4. Provides training and support for budgets, coverage analyses, and billing for assigned area(s). Reviews and finalizes budgets and coverage analyses in compliance with all regulations.
5. Provides clinical support and guidance for RN staff and serves as a clinical resource for coordinators and assistants.
6. Provides coaching, counseling, and guidance to staff as needed.
7. Works collaboratively with research and clinic staff to identify system and operational areas for improvement and growth opportunities. -
Conducts activities related to research coordination from study start-up to study closure (administrative/regulatory documentation and submissions, lab acquisition and processing, data extraction/entry, patient enrollment, scheduling/conducting patient visits, and completion of patient billing). Compiles and prepares reports from study questionnaires to provide analysis of study outcomes and results against expectations.
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Administers study medications and performs patient assessments during patient visits. Works in conjunction with providers to report all adverse events. Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment.
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Schedules and/or performs a variety of medical tests including, but not limited to, blood draws, vital signs, imaging studies, and cardiac and/or pulmonary function tests as needed per study protocol(s).
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Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, procedures, and protocols for research activities in noted area.
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Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Prepares budget analysis form according to study protocol procedures.
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Participates in a variety of professional development programs to ensure ongoing awareness and understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
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Performs miscellaneous job related duties as requested.
Phoenix Children's Mission, Vision, & Values
To advance hope, healing and the best healthcare for children and their families
VisionPhoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.
We realize this vision by:
- Offering the most comprehensive care across ages, communities and specialties
- Investing in innovative research, including emerging treatments, tools and technologies
- Advancing education and training to shape the next generation of clinical leaders
- Advocating for the health and well-being of children and families
- We place children and families at the center of all we do
- We deliver exceptional care, every day and in every way
- We collaborate with colleagues, partners and communities to amplify our impact
- We set the standards of pediatric healthcare today, and innovate for the future
- We are accountable for making the highest quality care accessible and affordable