Clinical Research Office

Description

The Clinical Research Office (CRO) has overall responsibility for the performance of cancer trials and other cancer research studies at the Samuel Oschin Comprehensive Cancer Institute and provides support and services to faculty and staff conducting oncology research. This includes coordination of staff support, provision of centralized systems, regulatory expertise, and quality assurance. 

Centralized systems will be easily accessible through the CRO website. These systems include a protocol library which will contain all active cancer-related protocols, a Protocol Review and Monitoring Committee online forum which will track documents and reviews, and a research manual with up-to-date documentation of standardized research procedures.

The goals of the CRO are to:

  • Facilitate, direct and coordinate cancer clinical research within the SOCCI
  • Serve as a single point of contact for research-related resources including protocol design, forms development, data coordination, and regulatory compliance
  • Support clinical research by providing a centralized, specifically trained, and supervised core staff of clinical research nurses, research coordinators, regulatory specialists, and data managers
  • Develop and maintain an active protocol library accessible by all SOCCI cancer researchers and staff
  • Assist in protocol review and assess the feasibility of clinical research studies within the SOCCI
  • Serve as a central resource for clinical research education, training and staff development for physicians, scientists and research staff
  • Develop and promulgate standards, policies, and procedures for the proper conduct of clinical research in accordance with ethical standards and in compliance with federal, state, and local regulatory requirements
  • Provide assistance and advice to investigators regarding FDA documentation including submission of IND applications; provide support for IRB submissions and communications
  • Facilitate clinical research by interfacing with research pharmacy, laboratory, pathology, medical records, budgeting, grants and contracts offices, and with external research sponsors
  • Collaborate with research informatics faculty and staff to provide standard databases for research; data management tools; and monitoring of study accrual

Staff

CRO Core Groups

MANAGEMENT

Christine Szekely, PhD, Director, Clinical Research Office

Regina R. Deck, RN, BSN, OCN, CCRP, Manager, Clinical Research Operations

Therica Miller, MBA, Manager, Clinical Research Operations

Howard Sandler, MD, MS, FASTRO, Medical Director Clinical Research Office

Robin Bitting, Management Assistant II

REGULATORY

Therica Miller, MBA, Manager, Clinical Research Operations

Koty Mann, MA, Clinical Research Specialist, Regulatory Lead

Jacob Edmondson, Regulatory Coordinator

Jenny Joaquin, Regulatory Coordinator

Rosalinda Massie, Regulatory Coordinator

BUDGET/FINANCE

Therica Miller, MBA, Manager, Clinical Research Operations

Joanne Pak, Budget Coordinator

Marcy Sturgess, Budget Coordinator

Natalya Semiletova, Budget Coordinator

Alice Trevino, Research Grant Specialist

TRAINING AND EDUCATION

Keri Ryback, RN, BSN, OCN, Clinical Research Specialist

Melanie Ozaki, MA, CCRP, Training and Education, Cooperative Group Lead

STUDY START UP

Therica Miller, MBA, Manager, Clinical Research Operations

Keri Ryback, RN, BSN, OCN, Clinical Research Specialist

Maria Buscemi, MPH, Protocol Review Monitoring Committee

Virginia Naessig, MSc, Study Intake Coordinator

Heather Chen, MPH, Clinical Research Specialist

PATIENT RECRUITMENT AND OUTREACH

Jaime Richardson, RN, BSN, Clinical Trials Recruitment Navigator

QUALITY MANAGEMENT CORE

Christine Szekely, PhD, Director, Clinical Research Office

Bonnie Piantadosi, MSW, MPH, Quality Assurance / Quality Control

Keri Ryback, RN, BSN, OCN, Clinical Research Specialist

Heather Chen, MPH, Clinical Research Specialist      

COOPERATIVE GROUP

Sheilah Hurley, MA, Senior Research Project Advisor

Melanie Ozaki, MA, CCRP, Training and Education, Cooperative Group Lead

RESEARCH INFORMATICS /OnCore

Mercedes Franco, CCRP, Clinical Research Specialist, OnCore

Mahendra Yatawara, MBA, Sr. Programmer Analyst, Lead

RESEARCH LAB

Regina R. Deck, RN, BSN, OCN, CCRP, Manager, Clinical Research Operations

Renata Paraventi, Clinical Research Associate

Jocelynn Suarez, CCRP, Clinical Research Associate

 

For clinical research team information see Clinical Research Groups

 

Contact Information

For more information about the Clinical Research Office, please contact Robin Bitting at:

Email: Robin.Bitting@cshs.org
Phone: (310) 423-2773
FAX: (310) 423-1998

Address: 
8700 Beverly Blvd.
Los Angeles, CA, 90048