Phoenix Children's Hospital, Inc.
Clinical Research Coordinator New! BNI Research | Full-Time | Phoenix ...Read Mo
Phoenix Children's Hospital, Inc., Phoenix, Arizona, United States, 85003
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, including:
Review all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures 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 as required by regulations and sponsors With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants
Completes all tasks required by study sponsors, including:
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
Coordinates the process for opening new studies, including:
Obtains needed background material(s) on proposed research projects; presents findings and information to principal 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 Assists in development of workflow procedures for study team based on specific protocol
Participates in recruitment and selection of study participants and coordinates informed consent and entry into appropriate research studies ensuring inclusion and exclusion criteria are met Coordinates and schedules a variety of medical procedures/tests including laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol Provides study specific education to the participant and their family, including proper dosage/administration and disease treatment Reviews monthly financial reports, maintains inventory levels and initiates requisitions for replacement items Participates in professional development programs to ensure understanding of current methodologies and practices applied to the patient population and research area Performs miscellaneous job related duties as requested 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: 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 Values 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 Position Qualifications
Education 1. Bachelor’s degree in related field or equivalent combination of education and experience. Experience 1. One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations. Special Skills 1. Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines. 2. Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care. Additional Requirements 1. ACRP or SOCRA Clinical Research Certification (Preferred). 2. Clinical Research Training Certification (Preferred). 3. Phlebotomy Certification (Preferred).
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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, including:
Review all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures 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 as required by regulations and sponsors With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants
Completes all tasks required by study sponsors, including:
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
Coordinates the process for opening new studies, including:
Obtains needed background material(s) on proposed research projects; presents findings and information to principal 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 Assists in development of workflow procedures for study team based on specific protocol
Participates in recruitment and selection of study participants and coordinates informed consent and entry into appropriate research studies ensuring inclusion and exclusion criteria are met Coordinates and schedules a variety of medical procedures/tests including laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol Provides study specific education to the participant and their family, including proper dosage/administration and disease treatment Reviews monthly financial reports, maintains inventory levels and initiates requisitions for replacement items Participates in professional development programs to ensure understanding of current methodologies and practices applied to the patient population and research area Performs miscellaneous job related duties as requested 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: 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 Values 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 Position Qualifications
Education 1. Bachelor’s degree in related field or equivalent combination of education and experience. Experience 1. One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations. Special Skills 1. Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines. 2. Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care. Additional Requirements 1. ACRP or SOCRA Clinical Research Certification (Preferred). 2. Clinical Research Training Certification (Preferred). 3. Phlebotomy Certification (Preferred).
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