Regulatory Coordinator, Department of Neurology - Georgetown University Medical Center

Location
Washington D.C.
Posted
Feb 20, 2017
Closes
Mar 31, 2017
Function
Management
Industry
Education, Healthcare
Hours
Full Time
Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Regulatory Coordinator, Department of Neurology - Georgetown University Medical Center

The Department of Neurology at Georgetown University is dedicated to three major goals: neurological education of students, residents and physicians, advancement of our scientific knowledge via research which will improve the diagnosis and treatment of neurological disorders and delivery of cutting edge neurological care to our patients. 

The Regulatory Coordinator prepares and manages regulatory submissions for clinical trials including; initial protocol Institutional Review Board (IRB) submissions, study renewals, amendments, close-outs, and other communication to the GU IRB via the eRIC system. Duties include but are not limited to:

  • Serves as liaison to pharmaceutical/industry clinical trial sponsors, the GU IRB, SEPCOM, research pharmacy, and clinical trial monitors, to generate and maintain documentation related to research protocol startup and implementation.
  • Ensures that all staff training is appropriately documented and maintained current.
  • Ensures the proper completion and storage of all regulatory documents according the GU IRB and sponsor requirements.
  • Provides technical support to the Dept. of Neurology Clinical Trials staff to ensure smooth and efficient operation of clinical trials team and will serve as a liaison to University Information Services.
  • Prepares and manages regulatory submissions to the GU IRB - including initial protocol IRB submissions, study renewals, amendments, close-outs, and other communication to the GU IRB via the eRIC system.
  • Performs administrative duties such as maintaining the website, submitting invoices, and requesting parking stickers and internet vouchers as needed.
  • Updates clinicaltrials.gov for investigator-initiated studies.
  • Prints and appropriately files all communication with clinical trial sponsors.
  • Prepares regulatory documentation for clinical trial monitor visits.Generates and maintains documentation related  to research protocol start-up and implementation for clinical trial sponsors and the GU IRB, including training documentation, financial disclosures, and human subjects protection training

Requirements

  • Bachelor's degree
  • 1 year related/applicable experience
  • Administrative experience and a working knowledge of clinical trials and regulatory affairs - preference for experience working in clinical trials, research, lRB, ethics review board, medical setting, and/or regulatory affairs, and preference for experience with the GU eRlC system
  • Working knowledge of compliance policies with respect to the clinical regulatory environment
  • Working knowledge of protection of human subject, HIPAA requirements, and compliance with respect to the clinical regulatory environment
  • Ability to work independently and collaboratively with investigators, team members , and research subjects
  • Willingness and ability to learn how to update and maintain the department website
  • Ability to read and clearly understand clinical trial protocol
  • Excellent organizational and communication skills
  • Competency in computer use and web-based applications
  • Attention to detail and self-directed

Submission Guidelines:

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Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability status, protected veteran status, or any other characteristic protected by law.