18 days old

PROGRAM MANAGER II (Regulatory Specialist) - T68919

UAB Medicine
Birmingham, AL 35203
  • Job Code
    127214
Primary Location University
Job Category:Clerical & Administrative
Organization:311202000 Emerg Med-Research
Employee Status:Regular
Shift:Day/1st Shift
Description
!*!

The University of Alabama at Birmingham (UAB) is seeking an energetic and experienced Regulatory Specialist to support the rapid expansion of the Emergency Medicine Research Division and its mission to carry-out multi-disciplinary clinical trials, patient-centered research, and broad public health service programs regulated by the UAB-IRB and third-party agencies (e.g., WIRB). 


This position will also be capable of managing numerous active protocols that address a broad array of medical topics, disease conditions, patient populations and risk levels with oversight from physician-level scientists. Work with UED investigators and study staff to identify regulatory challenges for new studies and appropriate methods to achieve regulatory compliance


Responsibilities:

  • Prepare and submit research protocols and clinical trials billing forms for review by regulatory board, including revising and editing protocols and regulatory documents following review by UAB-IRB Officers
  • Maintains existing protocols including amendments, annual renewals, and problem summary/ adverse events reports
  • Organize and maintain print and electronic regulatory documents and records for pending, active, and closed research protocols
  • Support efforts to prepare for site initiation visits, routine site visits and audits by the sponsor or IRB Office
  • Other duties/responsibilities as needed


Annual Salary Range: $52,228.8 - $82,867.2



Qualifications
@!*!

Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. 


The ideal candidate will have 3-5 years of regulatory experience and the ability to independently manage high level regulatory and administrative duties necessary to start-up and maintain federally- and industry-sponsored research and public health interventions. 


The ideal candidate will also have knowledge and expertise in standard protocol submission, renewal and close-out procedures, adverse event and serious adverse event reporting, single-site and multi-site IRB policies and procedures, and ICH-GCP regulations and policies. 


Categories

Posted: 2020-02-09 Expires: 2020-03-11

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PROGRAM MANAGER II (Regulatory Specialist) - T68919

UAB Medicine
Birmingham, AL 35203

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