Regulatory Administrator

Position Information

University Code 34121 University Title Assistant Research Administrator 1 University Job Family Research - Support ORP Eligible No For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Multi Title Scope of Search Local Working Title Regulatory Administrator Position Number 583760 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Non-Exempt Employee Group University Employee Department Internal Medicine Organizational Overview

At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.

Position Primary Purpose and General Responsibilities

Deliver exceptional Institutional Review Board ( IRB ) and related regulatory support to the Principle Investigator (PI) and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant safety and welfare. Additionally, perform research associates tasks on assigned clinical research and clinical trial projects. Including, but not limited to, database searches, contact with sponsors and CROs, prepare and collect prescreening logs, screening logs, enrollment logs, informed consent checklists, eligibility checklists, serious adverse event reporting process and logs and collaborate with the PI to ensure and verify all documentation is complete.

Minimum Hiring Standards

• Two years of experience performing regulatory or related job functions, or a combination of equivalent experience, education and training.
• Independent judgment and critical-thinking skills required.
• Ability to demonstrate successful implementation of time management skills.
• Ability to multi-task and prioritize autonomously.
• Demonstrated leadership experience.
• Exceptional attention to detail and data accuracy.
• Ability to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.
• Detail-oriented
• Exceptional organizational skills
• Proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel, spreadsheet management, PDF file creation/use, online database use/maintenance, internet-based research, network & online file maintenance & management, and custom report generation. Demonstrated knowledge of medical terminology.
• Ability to provide own transportation to attend meetings within the service area or at training locations.
• Ability to work in a diverse environment.

Preferred Hiring Standards

• Experience with chart abstraction.
• Experience with clinical research activities, conduct, and regulatory submissions.
• Experience with Institutional Review Boards ( IRB )
• Experience with Oncore or other clinical trial management system ( CTMS ).
• Bachelor’s degree with experience in an academic medical center preferred or equivalent experience, education and training.

Required Licenses/ Certifications Anticipated Hiring Range $40,000 - $48,000 Application Process/Additional Information Campus MCV Campus Hours/Week 40 hours weekly Normal Work Days/Hours Monday - Friday, 8:00 am - 5:00 pm Job Open Date 04/16/2021 Posting will close on or before Open Until Filled Yes Job Category Research Is this a restricted position? Yes Is this position eligible to participate in alternative work arrangements? No Sensitive Position No Resource Critical Yes Quick Link Posting Specific Questions

Required fields are indicated with an asterisk (*).

  1. * Please describe your work experience, education, and training that is directly related to this position.

    (Open Ended Question)

  2. * Please describe your experience pertaining to IRB submissions and communications with an IRB.

    (Open Ended Question)

  3. * Please describe your proficiency in Microsoft Word, Excel, Access, or other related technology systems.

    (Open Ended Question)

  4. * Please describe the way you prioritize your work and tasks when presented with multiple projects concurrently

    (Open Ended Question)

Optional & Required Documents
Required Documents Optional Documents
  1. Cover Letter/Letter of Application
  2. Resume

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