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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Sporkenbach, Bettina R.N., BSN
Certifications
Education

R.N.

Business Address 1090 W. California Ave.
Mill Valley, CA 94941
Contact information
Telephone:
Email address:
Specialties

Clinical Operations

Clinical Trial Management

Experience

 

  • Project Management (International experience)
  • Vendor Management (Clinical, Data, IVRS, etc)
  • Study planning and timeline development
  • Protocol design/writing
  • Case Report Form (CRF) design
  • Clinical Study Report (CSR) writing / appendices compilation
  • SAE narrative writing or QC
  • SAE reconciliation (Clinical data base / SAE source docs)
  • SOP writing
  • Study file maintenance and system development
  • Site payment management and system set up
  • Site liaison (Site recognition activities)
  • Study metrics tracking
  • Data (Tables, listings, graphs) reviews
  • Informed Consent Form (ICF) reviews and designs
  • Regulatory document package review
  • Study Reference Tool design (Manuals, guidelines)
  • Budget generation and tracking
  • Investigator site selection and evaluations
  • Site monitoring visit conduct (Qualifications through Close-outs)
  • Monitoring Visit Report reviews
  • Clinical Research Associate (CRA)/Study Coordinator training
  • GCP/ICH training
  • Tracking tool development
  • Query resolution support or QC
  • Investigator meeting material preparations
  • Meeting facilitation (interdisciplinary groups)
  • FDA audit preparations (sponsor and sites)
  • Clinical Operations process development and documentation

 

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