Office of the Clinical Director at CCR
Leadership
- Oversight of clinical care, patient care and quality assurance
- Management of the scientific review process
- Clinical research training
- Regulatory oversight and compliance monitoring
- Authorization of medical staff credentials
- Supervision and management of OCD program offices
- Patient safety, clinical operations and administration
- Managerial oversight of policies and procedures
Biostatistics and Data Management Section
Seth Steinberg, PhD
Head, Biostatistics and Data Management Section
240.276.5563
steinbes@mail.nih.gov
- Statistical design and review of clinical trials
- Data analysis
- Consultation on statistical topics
Clinical Pharmacology Program
William Doug Figg Sr., PharmD, MBA
Senior Investigator and Program Director
240.760.6179
figgw@mail.nih.gov
- Clinical pharmacology
- Pharmacokinetics
- Pharmacogenetics
- Pharmacodynamics
- Pharmacometrics
- Bioanalytical assay development and validation
- Pharmacokinetic analyses
- Exposure/response analyses
- Nonclinical and clinical study design
- Pharmacogenomics
- Translational studies
- Molecular pharmacology
- Preclinical drug development
- Update patient/protocol files in database
- Assist with lab duties
- Request/ship specimens
- Monitoring, quality control/editing of data in laboratory database
- Isolation of cells and DNA for testing
- Specimen processing, receiving and shipping
- Clinical protocol design
- Clinical research support
- Patient care
- Pharmacokinetic analysis
- Preclinical data analysis
- Blood & Tissue Processing Core (BTPC) supervisor’s assistant
- Biospecimen coordinator & processor
- Process and store biological samples
- Operations management of Blood and Tissue Processing Core laboratory (BTPC)
- Coordination with research nurses
- Biospecimen collection resource for study design
- Processing samples from patients
- Extracting DNA and cells from blood
- Editing lab matrix data
- Shipping biological material
- Specimen processing, receiving and shipping
- Isolation of cells and DNA for testing
Clinical Research Support Services
- Contracts
- Data management
- Monitoring
- Clinical research databases
Medical Oncology Service
- Medical oncology quality
- Medical oncology efficiency
- MOS clinical fellowship programs
Office of Education and Compliance
- Clinical research orientation and continuing education
- Clinical research compliance
- Regulatory consultation
- CCR polices and SOPs
Office of Sponsor and Regulatory Oversight
- Managing and overseeing OSRO resource allocation, activities and contracts
- COR for OSRO support contract
- Safety Oversight and SAE evaluation
- FDA Sponsor Representative
Rita Misra, PhD, MPH
Supervisory Regulatory Affairs Specialist/FDA Strategy and Communication Lead
301.624.8763
misrar@nih.gov
- Oversees INDs, IDEs and master files
- Coordinates FDA meetings and communications
- Facilitates exchange of information between CCR and Pharma collaborators
- IND management
- IND management
- IND management
- Document management
- CMC and quality expertise
Jeff Carrico, PharmD, BCPS
Lead, Operations and Investigational Drug/Device Research
240.276.7614
jeffery.carrico@nih.gov
- Pharmaceutical support / investigational agent support
- Oversight and regulatory compliance
- Clinical site monitoring
- Essential regulatory documents
- Clinical site monitoring
- Essential regulatory documents
Joni Love, RN, BSN
Safety Oversight Coordinator, Task Area Leader Safety
240.276.6628
joni.love@nih.gov
- Serious adverse reporting for CCR held INDs
- Serious adverse reporting for CCR held INDs
- Safety oversight
- SAE evaluation
- Signal detection
- Safety oversight
- SAE evaluation
- Signal detection
Barbara (Barb) Butler, PhD
Clinical Quality Assurance Specialist
240.276.6463
barbara.butler@nih.gov
- Quality management system
- Document control
- Training
Office of Research Nursing (ORN)
- ORN staffing, policy, and initiatives
- ORN and branch collaborations
- Manage team of research nurses in the ORN
- Support professional development of research nurses
- Provide mentorship and team building support
- Manage team of research nurses in the ORN
- Support professional development of research nurses
- Provide mentorship and team building support
- Manage team of research nurses in the ORN
- Support professional development of research nurses
- Provide mentorship and team building support
- Manage team of research nurses in the ORN
- Support professional development of research nurses
- Provide mentorship and team building support
- Manage team of research nurses in the ORN
- Support professional development of research nurses
- Provide mentorship and team building support
Protocol Support Office
- Protocol navigation oversight and activities
- Scientific review committee (SRC) administration
- Safety monitoring committee (SMC) administration
- IRBO/OHSRP liaison
Office Administration
- Administrative and programmatic support to the Office of the Clinical Director
- Office of Research Nursing administrative support