Oncology Research Regulatory Coordinator.
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POST DATE 10/11/2017
END DATE 12/28/2017
Saint Barnabas Health Care System
JOB DESCRIPTIONONCOLOGY RESEARCH REGULATORY COORDINATOR.
Job Number: REQ28887-POS8987
Category: Oncology Nursing
Location: Newark, NJ
* Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
* Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB), Institutional Review Committee (IRC) policies and procedures and regulations. Manages identified issues and provides feedback to leadership regarding resolution.
* Disseminates information and participates in training.
* Provides direction and feedback to research team to ensure awareness of clinical practices and quality standards.
* Documents any exceptions to compliance standards.
* Manages new submissions and continuing review activities.
* Reviews initial submissions to determine review category and action to be taken.
* Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRC, the IRB and sponsoring entities.
* Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, legal, federal, and pharmaceutical).
* Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
* Attends research team meetings to report on regulatory issues.
* Responsible for administrative duties and acts as a liaison with legal, financial and sponsors corresponding to budgets and contracts.
* Performs related responsibilities as required.
* Excellent oral, written, and interpersonal skills; high attention to detail; ability to analyze medical research data and review experimental protocols; and working knowledge of word processing, Adobe Acrobat, spreadsheet, and database management programs.
* Must perform the job of the Clinical Research Nurse in her absence.
* Adhere to Guideline for Good Clinical Practice (GCP), federal, state and local regulations.
* Assure all site documents including SOPs and administrative files are maintained in audit-ready condition.
* Assists with internal and external audits and quality assurance activities including monitoring visits. Audits and inspections. Responds to audits and prepares Corrective Action Plans to prevent future deficiencies.
* Supports the cost effective financial aspects of the clinical trial.
* Assists the PI and other designated research staff in the preparation, submission and maintenance of the following study-related regulatory documents: Current and obsolete versions of the protocol and consent forms; FDA Form 1572 and or 1571; Protocol violations/deviations; Serious adverse events; Current and obsolete Investigation Drug Brochures; Documentation of IRB submissions and related correspondence, reports and letters; Current laboratory certifications and normal reference ranges; Research staff CVs and licenses, training materials and certifications; Investigation Products accountability forms, signature logs, delegation of duties log, etc.
* Perform duties such as filing, photocopying, faxing and distributing study-related documents.
* Maintain all study-related legal and financial documents in a confidential regulatory file.
* Bachelor's Degree in Nursing and two years of experience in a research environment, or an equivalent combination of experience, education and training.
* Knowledge of clinical research practices.
* Must complete all required training courses within one month of hiring date.
* Comprehensive knowledge of the principles, methods and procedures of basic medical and /or clinical research processes.
* Comprehensive knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.
* Comprehensive knowledge of GCP, federal, state and local regulations including HIPAA
* Licensed to practice Nursing in NJ or an equivalent
* Certificate in Human Subjects Protection and CITI Training Certificates in Biomedical and Conflict of Interest..