Clinical Research Regulatory Specialist

Job ID
2020-118694
Employment Type
Full Time
Department
Dignity Health Research Institute Administration
Hours / Pay Period
80
Facility
St Josephs Hospital and Medical Center
Shift
Day
Standard Hours
Mon-Fri 8-5
Work Schedule
8 Hour
Location
AZ-PHOENIX

Overview

Hello humankindness 

Located conveniently in the heart of Phoenix, Arizona, St. Joseph's 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. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's 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. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's 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. Joseph's among the top hospitals in the United States for neurology and neurosurgery.  In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.

Look for us on Facebook and follow us on Twitter.

 

For the health of our community ... we are proud to be a tobacco-free campus.

Responsibilities

Position 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. 
 
Principal Duties and Accountabilities:
  • 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

Education and Experience: 
  • Associate degree or equivalent combination of education and experience
  • Minimum 3-5 years related experience.
  • Associate Degree or equivalent combination of education and experience
  • Previous training in the area of regulatory submissions, research administration or other clinical trial experience.
  • Proficient to advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills.

Preferred

  • Preferred: Professional certification in research; CCRP, CCRC, CIP, or RAC.
  • Preferred: 5 + years of experience and Bachelor's degree.

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