Michael Van Werden has over 15 years of experience in clinical research as a Clinical Research Associate and Senior Clinical Research Associate. He has conducted monitoring visits and reviewed clinical data for trials across various therapeutic areas including endocrinology, neurology, dermatology, infectious diseases, and rheumatology. His responsibilities included training other staff, resolving data queries with study sites, and preparing project management reports. He holds a Bachelor of Sciences degree in Dietetics from Iowa State University with minors in Business and Spanish.

1. Michael Van Werden
San Diego, CA 92116
619-890-9873
e-mail: dockersii@yahoo.com
Professional Experience
Quintiles, San Diego, CA (1/2012 – 7/2016)
Sr. Clinical Research Associate III
 Conduct Monitoring and review (site selection, initiation, routine/interim, and close-
out visits) at investigator sites following FDA regulatory requirements (Good Clinical
Practices / ICH-GCP; 21 Code of Federal Regulations, ALCOA principles)
 Participate in site recruitment, selection and initiation activities for clinical trials
 Train junior CRAs on monitoring, internal procedures, and query resolution
 Additional tasks (as listed for previous CRA job)
Project Experience
III Endocrine / Diabetes / Biosimilar insulin for Type 1 diabetics
III Neurology / Diabetic Neuropathy
III Endocrine / Diabetes / Biosimilar insulin for Type 2 diabetics
III Endocrine / Diabetes / Type 2 diabetic oral medication
III Dermatology / Psoriasis / Biosimilar biologic treatment (injection)
PharmaNet, San Diego, CA
Clinical Research Associate II (02/2007 – 12/2011)
Clinical Research Associate I (05/2005 – 01/2007)
 Conduct Monitoring Visits (SSV, SIV, RMV/IMV, COV)
 Participate in site recruitment, selection and initiation activities for clinical trials
 Experience conducting eCRF review with various types of Electronic Data Capture
(EDC – InForm, RAVE, etc.); experience with IVRS & IWRS systems
 Review and verify CRFs and other clinical data for completeness, integrity and
accuracy; generate queries
 Maintain patient tracking records for multiple sites
 Train site staff
 Resolve queries of CRF data with study site personnel
 Prepare and process Serious Adverse Event (SAE) reports
 Prepare project management reports for clients, project personnel, and internal
management
 Review of Informed Consents (ICFs)
 Assistance in development of source documents
 Experience with multiple Central/local labs; Central IRBs and Quality of Life surveys
 Manage time well and follow through on pending issues/action items until completion

2. Michael Van Werden Page 2
Project Experience
Phase Therapeutic area, Sub Indication and Drug Class
I/II Endocrine / X-Linked Hypophosphatemia (human monoclonal antibody)
II Endocrine / Oral Testosterone Undecanoate (TU) in Hypogonadal Men
II Coronary / carotid stenosis
II Infectious disease / West Nile Virus / immunizations / vaccine
II Nervous / chronic lower back pain / TNF-α inhibitor
III Rheumatology / rheumatoid arthritis / IL-6 inhibitor
II Infectious disease / vaccine for meningitis/ immunizations / vaccine
III Infectious disease / vaccine for meningitis/ immunizations / vaccine
IV Infectious disease / HIV
II Urology / erectile dysfunction / α-MSH analog
III Neurology / Parkinson’s Disease
BioPhase Solutions, San Diego, CA 02/2005 – 05/2005
Contracted to Structural GenomiX, San Diego, CA
Clinical Trial Assistant
Therapeutic areas – acute myeloid leukemia / solid tumors
 Prepared and sent regulatory packets including confidentiality agreements, protocol
synopsis, clinical study agreements, clinical trial agreements, Investigator’s
brochure, Feasibility Questionnaires and study budgets to Investigators
 Reviewed clinical documents for a newly in-licensed cancer drug in Phases I/II and
created a new filing system for them at Structural GenomiX
Education
Iowa State University, Ames, IA
(+2 courses: Human Pharmacology)
Bachelor of Sciences – Dietetics
Double Minor- Business, Spanish
Professional Memberships / Certifications
Professional Certification in Clinical Trials Management & Administration, University of
California, San Diego, CA, 2003
Biostator certification
Languages
English (fluent)
Spanish (fluent)