Diane Schulz Email & Phone Number

Conducted pre site visits, routine interim, remote and close out monitoring visits in compliance with ICH GCP for Phase 3 international Assessment for multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg - NAVIGATE ESUS 7,000 subjects event driven study, Bayer HealthCare

Conducted interim and close out monitoring visits in compliance with ICH GCP for Phase 3 international Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes – the ACCELERATE 10,000 subjects event driven study.

Conducted interim and termination visits in compliance with ICH GCP Guidelines and FDA regulations for GSK Phase IV Global Asthma study

New York, New York, Us

Conduct qualification, initiation, interim and close out monitoring visits in compliance with ICH GCP Guidelines and FDA regulations for Lilly Phase III, International Cardiovascular Study

Conducted initiation and interim monitoring visits in compliance with ICH GCP for Phase 3b international trials for Vertex Pharmaceuticals Hepatitis C study and Orexigen Therapeutics Major Adverse Cardiovascular Risk Factor (MACE) obesity trial.

Raleigh, North Carolina, Us

Conducted pre-site qualification, initiation, and interim monitoring visits in compliance with ICH GCP for Phase II and IV international multi-center gout studies.

Independent contract with clinical reserach group, Health Behavior Assessment. Performed clinical research SOP development and training on FDA and ICH GCP guidelines for clinical studies. Conducted project management clinical pre-study start up activities.

Sr. CRA (Clinical Quality Services, LLC contractConducted site initiation and interim monitoring visits. • Phase III, 7,800 adult subject international pivotal FLUAD influenza vaccine trial. • Phase IIIb, 12,000 pediatric subject international MENACY meningococcal vaccine trial. • Phase II-III H1N1 multicenter, pediatric vaccine trial.

Conducted site initiation and interim monitoring visits. • Phase III, 7,800 adult subject international pivotal FLUAD influenza vaccine trial • Phase IIIb, 12,000 pediatric subject international MENACY meningococcal vaccine trial • Phase II-III H1N1 multicenter, pediatric vaccine trial

Contract position, phase III oncology studyMonitored medical device company

Co-managed clinical trial project activities for pharmacokinetic, respiratory, and cardiovascular risk product exposure studies managing effectivley within budget limits. Conducted CRA activities as qualification, initiation, interim and close out monitoring visit of Investigator sites, generated monitor plans and reports,while tracking protocol deviations and adverse events. Quality Assurance activities included facilitating development, and training of clinical SOPs and identified CRO performance metrics documenting deviations and action plans.

Coordinated domestic/international drug & sample shipments for Phase I-III and IIIb clinical trials. • Coordinated validation of drug storage facilities according to GMP guidelines. • IHCRA experience monitoring diary entries, query resolution and product accountability.• Wrote departmental SOPs and study related training materials.Projects/Indications: Type II Diabetes, PCOS, Metabolic Disorder, and Immunology studies.

Clinical Research Associate, Clinical Research

Bs Medical Technology/Chemistry, Clinical Chemistry, Hematology, Immunology, Microbiology, Virology, Blood Banking

Bs Medtech, Clinical Science-Chemistry