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Job Requirements of Clinical Research Regulatory Project Manger:
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Employment Type:
Full-Time
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Location:
Phoenix, AZ (Onsite)
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Clinical Research Regulatory Project Manger
Hello humankindness (
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Located conveniently in the heart of Phoenix, Arizona, (
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 (
_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 (
_For the health of our community ... we are proud_ _to be_ _a tobacco-free campus._
**Responsibilities**
Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist(s) in accordance with all applicable institutional, state, federal laws and regulations. Supervision includes coordination of activities with physician-investigators in providing guidance and interpretation of local policies; emphasis is needed relative to Catholic governance obligations of Dignity Health to comply with ethical standards in the operations of clinical research. Requires subject matter expertise and demonstrated working knowledge of ICH, HHS, and FDA regulations pertaining to the ethical conduct of research.
Responsibilities include daily operational guidance to all SJHMC/BNI investigators requiring independent judgment and strong critical thinking skills relative to human subject research regulations to ensure the safe and ethical conduct of research. Under the direction of the Research Integrity and Compliance Officer, may serve as primary contact in support of site initiation and monitoring visits performed by pharmaceutical and device manufacturing clinical trial sponsors.
**Qualifications**
Experience
Five years of related experience.
Seven + years of related experience preferred.
Education
Bachelor's degree or equivalent combinations of education and experience required.
Master's degree preferred.
Licensure
Preferred: Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred
Special Skills
Proficient to advanced computer skills; proactive; strong organizational skills; demonstrated knowledge of organizational and administrative support processes.
Demonstrated proficiency taking and transcribing notes and minutes and/or formal proceedings.
Excellent verbal and written communication and interpersonal skills.
Training
Experience in the area of biosafety, animal care and use, institutional ethics review, research administration, audit or other area of research, compliance or oversight.
**Pay Range**
$30.55 - $44.30 /hour
We are an equal opportunity/affirmative action employer.
Recommended Skills
- Administration
- Auditing
- Biosafety
- Certified Irb Manager
- Clinical Research
- Clinical Research Coordination
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Job ID: NDQ5NzoyNjc1MTAwNjE
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