Research Regulatory Specialist Job at St Joseph Hospital & Medical Center
St Joseph Hospital & Medical Center Phoenix, AZ 85013
$22.95 - $33.28 an hour
Overview
Hello humankindness Located conveniently in the heart of Phoenix ArizonaSt. Josephs Hospital and Medical Center is a 571-bed not-for-profit hospital that provides a wide range of health social and support services. Founded in 1895 by the Sisters of Mercy St. Josephs was the first hospital in the Phoenix area. More than 125 years later St. Josephs remains dedicated to its mission of caring for the poor and underserved.We are extremely proud to be a nationally recognized center for quality quaternary care medical education and research. St. Josephs includes the internationally renowned Barrow Neurological Institute Norton Thoracic Institute Cancer Center at St. Josephs Ivy Brain Tumor Center and St. Josephs Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics neuro-rehabilitation orthopedics and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.U.S News & World Report routinely ranks St. Josephs among the top hospitals in the United States for neurology and neurosurgery. In addition St. Josephs boasts the Creighton University School of Medicine at St. Josephs and a strategic alliance with Phoenix Childrens Hospital.St. Josephs is consistently named an outstanding place to work and one of Arizonas healthiest employers. Come grow your career with one of Arizonas Most Admired Companies.Look for us on Facebookand follow us on Twitter.For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities
SUMMARY - The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits. Demonstrated
knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required. This position interacts with a variety of customers,
both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high volume clinical trial setting is required.
Qualifications
MINIMUM
PREFERRED
Pay Range
$22.95 - $33.28 /hour
Hello humankindness Located conveniently in the heart of Phoenix ArizonaSt. Josephs Hospital and Medical Center is a 571-bed not-for-profit hospital that provides a wide range of health social and support services. Founded in 1895 by the Sisters of Mercy St. Josephs was the first hospital in the Phoenix area. More than 125 years later St. Josephs remains dedicated to its mission of caring for the poor and underserved.We are extremely proud to be a nationally recognized center for quality quaternary care medical education and research. St. Josephs includes the internationally renowned Barrow Neurological Institute Norton Thoracic Institute Cancer Center at St. Josephs Ivy Brain Tumor Center and St. Josephs Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics neuro-rehabilitation orthopedics and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.U.S News & World Report routinely ranks St. Josephs among the top hospitals in the United States for neurology and neurosurgery. In addition St. Josephs boasts the Creighton University School of Medicine at St. Josephs and a strategic alliance with Phoenix Childrens Hospital.St. Josephs is consistently named an outstanding place to work and one of Arizonas healthiest employers. Come grow your career with one of Arizonas Most Admired Companies.Look for us on Facebookand follow us on Twitter.For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities
SUMMARY - The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits. Demonstrated
knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required. This position interacts with a variety of customers,
both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high volume clinical trial setting is required.
Qualifications
MINIMUM
High School Diploma
2 years related experience
Proficient to advanced computer skills; proactive strong organizational skills.
Excellent verbal and written interpersonal skills
Excellent verbal and written interpersonal skills
Previous training in the area of regulatory submissions, research administration or other clinical trial experience
PREFERRED
Bachelor's degree in related field
Preferred: Professional certification in research; CCRP, CCRC, CIP, or RAC.
Pay Range
$22.95 - $33.28 /hour
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