Download OHC Research Presentation - International Association of Clinical

OHC Research
BRITTANY HAGEN BS RN OCN CCRC
CLINICAL RESEARCH MANAGER
OHC, INC.
OHC – An Overview
 Founded in 1985, OHC is the Largest Private Oncology Practice in
the Region
 Oncology Medical Home
 Specialists in Cancer and Blood Disorders
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Medical Oncology, Radiation Oncology, Gynecologic Oncology, Neuro
Oncology, Blood Cancers and Palliative Care
Performed More Bone Marrow Transplants than Any Other Provider in
Region
 17 Offices - Ohio, Kentucky and Indiana
 7 Offices with Research Staff On Site
 Partnership with Sarah Cannon Research Institute
 Largest Clinical Trial Menu in Region
 More than 120 Available Clinical Trials
 TWICE Received ASCO’s Clinical Trials Participation Award
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Nationwide, Only TWO Practices Have Received This Designation More Than Once
OHC Research – An Overview
 Leadership Team:
 Dave Waterhouse, Chair of Research
 Lynnetta Hart, Director of Research
 Brittany Hagen, Research Clinical Manager
 Nicole Given, Research Non-Clinical Manager
 Staff:
 12 Research Nurses
 3 Research Assistants
 3 Regulatory Specialists
 6 Data Managers
 1 Budgets & Contracts Specialist
 1 Personalized Medicine Navigator
 1 Research Blood Cancer Program Coordinator
 1 Administrative Assistant
OHC Research
 What Types of Trials Do We Offer?
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Pharmaceutical Intervention Studies
Observational Studies
Chart Review Studies
Correlational Studies
 How Do Our Doctors Know About the Trials?
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Clinical Trial Review
Internal Communication
OHC Intranet
 How Do Patients Get Enrolled?
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MD Presentation
RN Discussion
OHC Research – Job Functions
 Regulatory
 Training, IRB Communications, Trial Management
 Data Management
 Data Entry, Query Resolution, Audit Preparation
 Research Assistants
 Lab Kit Assembly, Central Labs, Tissue Collection, Bone
Marrow Collection, EKGs, Imaging
 Clinical Research Data Nurses
 Query Resolution, SAE Reports and Follow-Ups, Audit
Responses, Screening
OHC Research – Job Functions
 Research Nurse
 ‘Study Coordinator’ and MORE
RN Requirement, Previous Experience in Oncology or Research
Preferred, Certifications Encouraged
 Nine pursuing BSN, MSN, MBA
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Screening, Enrollment, Study Visits, Protocol Assessments,
Submission of Clean Data, Coordination of Care
Documentation of Adverse Events, Concomitant Medications,
Assessments, Training
Works Closely with Investigators
Develops Relationships with Other OHC Non-Research Staff
Members
OHC Research – A Day in the Life
 Eight or Ten Hour Days
 Office Dependent
 Office Maintenance
 Temperatures, Drug Inventory, Filing Paperwork
 Emails, Emails, Emails
 Monitors, Sponsors and Internal
 Patient Visits
 Assess Patient, Dispense Drug, Training, Monitoring, Central Labs
 Documentation, Documentation, Documentation
 Screening
 RNs Responsible for New Patients, MDs Responsible for Existing
Patients
 Trainings
 SIVs, Investigator Meetings, OHC SOPs
OHC Research - Speedbumps
 Non-Research OHC Staff
 Buy-In
 Building Relationships
 Mutual Understanding of Job Functions
 Turnover
 Constant
 Sponsors, CROs
 Combatting the Loss
 Enrollment
 Ebbs and Flows
 Pressure from MDs, OHC, SCRI, Sponsors
OHC Research – Future
 Strategic Planning
 Phase I Opportunities
 First Phase I Trial Opened in March 2014
 Fourteen Through Today
 Inpatient Bone Marrow Studies
 Jewish Hospital BMT Unit
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Acute Leukemics, Graft Versus Host Disease
 Radiation Oncology Studies
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