Regulatory Coordinator- White Plains Hospital , 25 miles from Manhattan
Company: White Plains Hospital
Location: Yonkers
Posted on: April 8, 2021
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Job Description:
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
Keywords: White Plains Hospital, Yonkers , Regulatory Coordinator- White Plains Hospital , 25 miles from Manhattan, Healthcare , Yonkers, New York
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