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Clinical Research Resume


Desired Industry: Biotech SpiderID: 33057
Desired Job Location: Chicago, Illinois Date Posted: 1/25/2010
Type of Position: Full-Time Permanent Availability Date: 2/1/10
Desired Wage: 85000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Doctoral Willing to Relocate: No


Objective:
Over 14 years of experience in clinical research. Responsible for the initiation, execution, and continuous management of clinical research trials and registries. Accountable for ensuring study timelines and deadlines are met and kept within budget. Ensuring departmental research activities are maintained within regulatory compliance per FDA, NIH, GCP and IRB guidelines. Experience in hiring, supervising and mentoring research staff.


Experience:
Novian Health, Chicago IL
Clinical Research Manager, 2007 – 2010
• Directed all research operations around the initiation, approval and execution of a class III medical device multicenter breast cancer trial and registry
• Prepared presentations, materials and applications for FDA workshops, pre-filing meetings and IDE submissions
• Developed and launched the national ABLATE Patient Tracking Registry
• Oversaw R&D pipeline and budget
• Successfully negotiated and selected CRO and central imaging core lab
• Singlehandedly obtained IRB approvals for 30+ investigators
• Developed clinical study protocols and consent forms, tracking databases and CRFs
• Drafted company’s research SOPs and publication plan guidelines
• Prepared regulatory binders and related study forms; trained sites

Johnson & Johnson, Seattle WA
Research Site Manager, 2005 – 2007
• Managed the approval, startup and execution of a class III medical device orthopedic trial
• Obtained initial and continuing IRB approvals
• Recruited, consented and enrolled 45+ subjects into a multicenter hip replacement trial
• Maintained and updated regulatory documents, CRFs and device inventories
• Monitored and reported AEs; performed daily chart reviews
• Completed ongoing sponsor, investigator and study progress reports
• Designed and managed multiple research study databases and tracking spreadsheets
• Established and launched a Knee & Hip Joint Replacement Registry and an Orthopedic Research Foundation

Children’s Hospital & Regional Medical Center, Seattle WA
CRAII/Monitor, 2004 – 2005
• Coordinated the initiation and execution of a 60 site multicenter phase III cystic fibrosis drug trial
• Trained site research coordinators on all clinical trial activities (IVRS, protocol, study forms/logs, specimen shipping)
• Tracked and maintained regulatory documents for 60 sites
• Managed site IRB approval and activation status; lead site initiation conference calls
• Reviewed and approved site study budgets and consent forms
• Prepared and tabulated clinical summary progress reports
• Prepared regulatory binders; developed and edited internal SOPs, study forms/logs and work instructions

University of Washington at Harborview Medical Center, Seattle WA
Study Manager, 2001 – 2004
• Oversaw daily operations for the department of neurology and implementation of sleep disorder and ALS studies
• Hired and supervised a research staff of 11 interviewers and random-digit dialers
• Established the King County Narcolepsy Registry
• Completed hundreds of chart reviews within King County metro area; screened and enrolled 200+ study subjects
• Oversaw subject recruitment efforts and advertising budget ; approved quarterly departmental financial reports
• Obtained IRB approvals at 5+ sites
• Prepared annual NIH progress updates, grant renewals and monthly investigator reports
• Designed and managed multiple study tracking databases
• Developed study binder, consent forms, fact sheets and study posters; designed and maintained study website

Fred Hutchinson Cancer Research Center, Seattle WA
Field Operations Supervisor, 1999 – 2001
• Managed the implementation and daily field operations for an electromagnetic field and breast cancer study
• Hired, supervised and trained a staff of 5 field interviewers
• Screened and enrolled 200 subjects
• Scheduled and organized all field assignments in King County
• Prepared and submitted IRB applications; drafted consent forms, subject questionnaires and study ads
• Managed recruitment budget and study supply inventory

Park Nicollet Institute, Minneapolis MN
Research Study Coordinator, 1997 – 1999
• Coordinated daily research activities for the initiation and management of the Minnesota Health Partnership Study—a multicenter trial evaluating coordinated health care and disability management
• Supervised and trained 2 research assistants
• Developed complex study database and tracking system ; prepared internal monthly study reports
• Successfully directed all efforts around the pilot study
• Trained research coordinators at 10+ sites
• Obtained continuing IRB approvals and prepared annual funding agency reports
• Designed study forms and recruitment materials
• Organized and scheduled focus group, steering committee meetings and physician CME workshops
• Proofread and edited manuscripts, ran literatures searches


Education:
Doctorate in Health Administration, Warren University, Agora Hills CA - 2005
Certificate in Clinical Trials, University of Washington, Seattle WA – 2003
Masters in Health & Human Services Administration, St. Mary’s University, Minneapolis MN – 1999
Bachelors in Community Health Education, Minnesota State University, Moorhead MN - 1995


Affiliations:
CCRP & Member: Society of Clinical Research Associates
Member: Association of Clinical Research Professionals



Additional Information:
Publications
1. Velde, S., Phillips, L.E. 2003. Technology’s impact on control recruitment using random digit dialing. Clinical trials quarterly online newsletter: [Online]: www.ctquarterly.com

2. Velde, S. 2005. Evaluation study instrument. Interactions: The human-animal health connection, 23(2),12.

3. Velde, S. 2006. Template for guiding and evaluating animal-assisted therapy. [Online]. Available:
www.deltasociety.org/animalsresourcesresources.htm

4. Longstreth WT, Ton T, Koepsell T, Gersuk VH, Hendrickson A, Velde S. Prevalence of narcolepsy in King County, Washington, USA. Sleep Med 2009 Apr;10(4): 422-426.

Presentations
1. “Intervention Study Results: Older Adults and Animal Companions.” May 1999. St. Mary’s University, Mpls, MN.

2. “The Narcolepsy Study,” Sleep Disorders Support Group, Swedish Medical Center. October 2002. Seattle, WA.

3. “The Narcolepsy Study,” Public Service Announcement, KOMO-TV Channel 4. October 2002. Seattle, WA.

4. “The Narcolepsy Study,” Sleep Disorders Support Group, Harborview Medical Center. January 2003. Seattle, WA.

5. “Epidemiology of Narcolepsy,” Sleep Disorders Center Monthly Meeting, Harborview Medical Center. July 2003. Seattle, WA.

6. “How to Collect and Ship Pseudomonas aeruginosa Specimens,” Early Pseudomonas Infection Control Investigator’s Meeting. September 2004. Denver, CO.

7. “Clinical Update: The ABLATE Registry & Breast Cancer Study,” Corporate Launch Meeting, Novian Health. April 2008. Chicago, IL.

8. “The Novilase™ Breast Cancer Study,” FDA Pre-Filing Meeting, Office of Device Evaluation - Center for Device and Radiological Health. September 2009, Silver Spring, MD.



Reference:
Available upon request.


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