Clinical Research Coordinator

Position Details

Department : RSRCH-GRNT | Orthopedic Research Studies

Location : Phoenix

Shift : Mon-Fri, Days, 8am-5pm

Category : Research

Posting # : 933941

Employee Type : Full-Time

Position Summary

This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.

Position Duties

• 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 :

1. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area

2. Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis

3. Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors

4. With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants

1. Provides regulatory documents to sponsor in timely manner

2. Completes case report forms, data entry, and maintains source documentation for all study participants

3. Tracks and reports adverse events per sponsor and institutional guidelines

4. Coordinates research monitor visits and responds to all data queries

1. Obtains needed background material(s) on proposed research projects; presents findings and information to principal investigator

2. Completes feasibility questionnaires

3. Circulates the confidentiality disclosure and trial agreements to the appropriate parties

4. Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial

5. Assists in development of workflow procedures for study team based on specific protocol

Phoenix Children's Mission, Vision, & Values

Mission

To advance hope, healing and the best healthcare for children and their families

Vision

Phoenix 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 :

Values