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Regulatory Coordinator- White Plains Hospital , 25 miles from Manhattan


  • White Plains Hospital
  • 03/23/19
  • White Plains, NY
  • 10601
  • Full-Time
Job Title: Regulatory Coordinator
Department: Cancer Center Administration
Reports to: Cancer Program Director
JobType: Fulltime
Hours :Mon-Fri, 9:00A-5:00P

White Plains Hospital, a 292 bed, leading award-winning hospital, located 25 miles north of Manhattan, in White Plains, Westchester NY, is looking for a Regulatory Coordinator.

JOB SUMMARY
The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s), Cancer Program Director and in collaboration with the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of WPH and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Offices at WPH.

JOB RESPONSIBILITIES OF THE REGULATORY COORDINATOR
Work with principal investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with Food and Drug Administration (FDA) and local Institutional Review Board (IRB) policies.
Assure all site documents, including SOPs and administrative files, are maintained in audit-ready condition.
Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
Coordinate regulatory activities for multiple clinical research projects.
Assist in obtaining initial documents for clinical trial procurement and site selection.
Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol.
Compile research protocol documents and all materials required for regulatory submissions in compliance with institutional and federal policies.
Oversee new study initiation process and provide regulatory guidance/support throughout the duration of the project.
Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies.
Report pertinent safety data and deviation notifications (Unanticipated Problem report) to the IRB.
Maintain current and accurate documentation in the electronic regulatory binder(s).
Participate in required teleconferences, on-site meetings and off-site investigator meetings, as required.

JOB QUALIFICATIONS OF THE REGULATORY COORDINATOR
Bachelor's degree required, in relevant field preferred.
Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) preferred.
Current CITI training certification preferred. Minimum of one (1) year of experience in the field of regulatory documentation management or clinical research required.
Experience submitting IRB applications (new and amendments) preferred.
Knowledge of clinical trial federal, state and local regulations preferred.
Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required.
Excellent interpersonal and communication skills required.

WHITE PLAINS HOSPITAL AWARDS AND RECOGNITION
U.S. News & World Report - Best Regional Hospital - 2016/2017
Healthgrades Outstanding Patient Experience Award
Consumer Choice Award (12-time recipient )
Top 20 Most Beautiful Hospitals
Womens Choice Award - Americas Best Hospitals for Patient Experience
Magnet Recognized 2012 and 2016 (only 7% of hospitals in the US are currently Magnet designated)
AACN Beacon Award of Excellence for Critical Care - 2014 &2017
CEO Cancer Gold Standard
Womens Choice Award - Americas Best Hospitals for Cancer Care
And many more.

HOW TO APPLY
Please submit your CV for consideration. We will get in touch with you in two business days should you meet our qualifications.
EOE M/F

Term: Clinical Data Coordinator


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