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Supervisor, Clinical Research Ops

Company: Phoenix Children's Hospital
Location: Phoenix
Posted on: October 11, 2021

Job Description:

Position Summary

This position provides supervisory guidance to research coordinators in the designated area to ensure efficient operations with regard to work productivity and results, employee performance, and quality assurance. This position also serves the functions and is expected to perform the work of a Senior Research Coordinator for specific clinical trials at all phases of development. This position requires advanced-level knowledge and skills and will be responsible for mentoring and training research coordinators and assistants in the noted area. This position works independently in the acquisition of specimens, extraction of data from patient charts, and analysis of data per protocol as well as administrative / regulatory support to designated area(s) in accordance with all regulatory and legal requirements. This position reports to the Manager, Clinical Research Operations and to the director of the assigned area.

PCH Values

  • Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
  • Excellence in clinical care, service and communication
  • Collaborative within our institution and with others who share our mission and goals
  • Leadership that set the standard for pediatric health care today and innovations of the future
  • Accountability to our patients, community and each other for providing the best in the most cost-effective way.
Position Duties

  1. Supervises research coordinators in assigned area(s).
    • 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.
    • Oversees and coordinates data extraction and entry, ensuring quality control and compliance with protocol; oversees and coordinates the scheduling and efficient usage of resources; and participates in the development of operating goals and objectives for the unit; recommends, implements, and administers methods and procedures to enhance operations, as appropriate to the department.
    • Coordinates orientation and training for new clinical research staff. Assists with the identification of staff community learning needs; administers training where needed.
    • Provides coaching, counseling, and guidance as necessary. Recommends personnel actions to department management.5. Works collaboratively with research and clinic staff to identify system and operational areas for improvement and growth opportunities.
    • Coordinates the completion of research Standard Operating Procedures (SOPs) for assigned department(s). Assists with the implementation of SOPs as needed.
    • Provides feedback during the process of changing, updating, or developing new policies and procedures in the research department. Works with management to implement new policies and procedures throughout the research department and institution.
  2. Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties.
    • Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, procedures, and protocols for all research activities in designated area.
    • Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis
    • Maintains compliance with current and accurate documentation in the regulatory binders (paper or electronic) as required by regulations and sponsors.
    • With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants.
    • Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
  3. Coordinates the process for opening new studies.
    • Obtains needed background material(s) on proposed research projects; presents findings and information to attending physician/principle investigator.
    • Completes feasibility questionnaires.
    • Circulates the confidentiality disclosure and trial agreements to the appropriate parties.
    • Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial.
    • Develops work flow procedures for study team based on specific protocol.
  4. Completes all tasks required by study sponsors.
    • Provides regulatory documents to sponsor in timely manner.
    • Completes case report forms, data entry, and maintains source documentation for all study participants.
    • Tracks and reports adverse events per sponsor and institutional guidelines.
    • Coordinates research monitor visits and responds to all data queries.
  5. Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
  6. Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
  7. Coordinates and schedules a variety of medical tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests, as needed to establish initial patient baselines for study.
  8. Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
  9. Performs miscellaneous job related duties as requested.

Keywords: Phoenix Children's Hospital, Phoenix , Supervisor, Clinical Research Ops, Other , Phoenix, Arizona

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