Supervisor, Clinical Research Ops
Company: Phoenix Children's Hospital
Posted on: October 11, 2021
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
- Family-Centered care that focuses on the need of the child
first and values the family as an important member of the care
- 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.
- 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
- 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
- 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
- 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.
- 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
- 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
- Coordinates research subject informed consent and entry into
appropriate research studies ensuring that all inclusion and
exclusion criteria are met.
- Coordinates the process for opening new studies.
- Obtains needed background material(s) on proposed research
projects; presents findings and information to attending
- 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
- Develops work flow procedures for study team based on specific
- 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
- Coordinates research monitor visits and responds to all data
- 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
- 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.
- 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.
- 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
- Performs miscellaneous job related duties as requested.
Keywords: Phoenix Children's Hospital, Phoenix , Supervisor, Clinical Research Ops, Other , Phoenix, Arizona
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