WhitePlainsRecruiter Since 2001
the smart solution for White Plains jobs

Regulatory Coordinator- White Plains Hospital , 25 miles from Manhattan

Company: White Plains Hospital
Location: White Plains
Posted on: June 21, 2020

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, White Plains , Regulatory Coordinator- White Plains Hospital , 25 miles from Manhattan, Healthcare , White Plains, New York

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Nurse Manager of Surgical Intensive Care Unit SICU
Description: A Magnet designated hospital located on the North Shore of Long Island is currently searching for an experience Nurse Manager of Surgical Critical Care Unit to join their accredited healthcare team. (more...)
Company: Nurse Management
Location: Hempstead
Posted on: 07/15/2020

PICU Pediatrics Intensive Care Travel RN
Description: Nationwide Travel Nurse Jobs - Pediatric Intensive Care RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for (more...)
Company: HealthCare Employment Network
Location: Hicksville
Posted on: 07/15/2020

Assessment RN Recent RN graduates may apply. $10,000 sign on bonus or student loan assistance
Description: Job DescriptionAs an employer, MJHS attracts individuals who see their work as a calling as well as a job. Professionals in every job category have cited that they appreciate being left to make their (more...)
Company: MJHS
Location: White Plains
Posted on: 07/15/2020


Nursing
Description: ABOUTBy the very nature of their duties, Navy Nurses quickly rise to the top of their profession. They provide care, not only for military servicemembers and their families, but also for people in need (more...)
Company: Navy
Location: Levittown
Posted on: 07/15/2020

PICC RN Contractor
Description: TASKS AND RESPONSIBILITIES: br ul br li Ability to work independently. li Communicates effectively and appropriately to patient, family and other health care providers. li Completes required (more...)
Company: TridentCare
Location: West Orange
Posted on: 07/15/2020

Registered Nurse
Description: HumanEdge is looking to hire a Registered Nurse to work in an LTC Rehabilitation facility in Freeport, NY. br br ul br li Immediate start br li Full time and Per Diem br li 8-hour shifts, (more...)
Company: HumanEdge
Location: Freeport
Posted on: 07/15/2020

ICU Trauma Unit Travel Nurse RN
Description: Nationwide Travel Nurse Jobs - Trauma ICU RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified registered (more...)
Company: HCEN
Location: White Plains
Posted on: 07/15/2020

Licensed Practical Nurse (LPN)
Description: HumanEdge is looking to hire a Licensed Practical Nurse to work in a Premiere Skilled Nursing facility located in a beautiful residential neighborhood of Wayne, NJ br br ul br li Immediate start (more...)
Company: HumanEdge
Location: Wayne
Posted on: 07/15/2020

Speech-Language Pathologist (SLP)
Description: FULL TIME POSITION br br Genesis Rehab Services is a leading provider of Physical, Occupational, Speech and Respiratory Therapy for older adults in skilled nursing facilities, independent and assisted (more...)
Company: Genesis Rehab Services
Location: West Orange
Posted on: 07/15/2020

Travel Nurse RN Intensive Care Unit (ICU)
Description: Nationwide Travel Nurse Jobs - Intensive Care Unit RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: HCEN
Location: Westport
Posted on: 07/15/2020

Log In or Create An Account

Get the latest New York jobs by following @recnetNY on Twitter!

White Plains RSS job feeds