Brad Brush Email and Phone Number

Responsible for monitoring of clinical study sites, as laid out in ICH/GCP Chapter 5.18 Duties and Responsibilities (including but not limited to): • Protocol and CRF review. • Development of informed consent forms. • Development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials. • Development and implementation of innovative approaches for and participates in site recruitment, selection and initiation activities.• Investigator meeting activities including organization, preparation and attendance• Follow up of drug safety issues and safety reports in timely manner, if applicable• Conduct on the job training and formal training for new CRAs• Provide scientific and clinical education to other team members• Creation of tools, formula sheets and screening cards.• Collaboration with Data Management in strategies for CRF and query completion.Senior Site Manager Activities - Conduct regular monitoring visits; prepare follow-up reports for sponsors and the establishment of an audit trail• Assure patient safety, adherence to protocols, SOPs, GCP and ICH guidelines• Site training• Site Initiation, routine monitoring visits, and site close out visits Provide advice/guidance query resolution, protocol violation.• Principle clinical and technical contact for international studies.• Creation of tools, formula sheets and screening cards.• Creation of remote training materials• Reconciliation of study medication.• Study promotion, subject enrolment and retention.Specialties: Clinical Trial Experienceo Inflammatory: Scleroderma, Psoriatic arthritis, rheumatoid arthritiso Respirology: Asthma, COPD, rhinitiso Oncology: Squamous cell carcinoma, AMLo Gastroenterolgoy: GERD, ulcers, ulcer rebleedingo Psychiatry: GAD, Schizophreniao Virology: Hepatitis CResearch Experienceo Cell culturing, transfection and transformationo Monoclonal antibody productiono Virus productionClinical (Hospital) Experienceo Hematologyo Clinical Chemistryo Microbiologyo Pathology