Clinical Research Regulatory Specialist

Job ID
2020-121608
Employment Type
Full Time
Department
Research IVY Brain Center
Hours / Pay Period
80
Facility
St Josephs Hospital and Medical Center
Shift
Day
Standard Hours
Monday - Friday (8:00am - 5:00pm)
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 InstituteNorton Thoracic InstituteCancer Center at St. Joseph'sIvy 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

ivy-logo

 

The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients.

 

The Ivy Clinical Research Regulatory Specialist is responsible and accountable for ensuring 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 FDA submissions such as INDs and IDEs, 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 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.

 

Principal Duties and Responsibilities:


• Oversees administrative functions of regulatory submissions to internal and external Institutional Review Boards (IRB) and provides support to investigators and study team members.
• Ensures proper compliance with institutional policies and procedures to ensure Dignity Health’s compliance with Federal, State and local laws/regulations.
• Liaison between IRB, investigators, program managers, study team and industry sponsors. Acts as primary point of contact for industry sponsors relating to regulatory issues.
• Coordinate and oversee all regulatory activities for multi-center clinical trial(s), preparing and compiling all reporting information needed for IRB, FDA and industry sponsors.
• Create, maintain and archive documents into the Trial Master File (TMF) for multi-center clinical trial(s) as well as the Investigator Site File (ISF) for the Dignity Health site per ICH GCP and FDA regulations.
• Provide status updates of initial approvals, amendments, renewals and post-approvals to management.
• Maintains in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protections.
• Ensures new protocols are submitted to the IRB within established time frames by compiling and coordinating appropriate paperwork.
• Reviews incoming protocol amendments and revisions from sponsors, identifying necessary steps for processing, and consulting with Principal Investigator, Program Managers and other staff as needed.
• Completes, maintains and updates study regulatory/legal documents per guidelines.
• Maintains investigator CVs and medical licenses, staff CVs and licenses, training certificates.

 

Qualifications

Required Qualifications:


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

 

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