Manager Quality Assurance
Resume:
Stephen Mekonis
Email: abqocg@r.postjobfree.com
Address: **** ***** ***** **** ****
City: Raleigh
State: NC
Zip: 27616
Country: USA
Phone: 919-***-****
Skill Level: Experienced
Salary Range: $80,000
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
CURRICULUM VITAE
Stephen Mekonis
ADDRESS: 5240 Holly Ridge Farm Road
Raleigh, NC 27616
Home: 919-***-****
EDUCATION:
September 1994 to Medical College of Pennsylvania and Associate Degree of Science in
May 1996 Hahnemann University Nursing
Philadelphia, PA
September 1988 to Temple University Bachelor of Arts in Biology
August 1992 Philadelphia, PA
PROFESSIONAL EXPERIENCE:
May 2010 to HOMEBASED / STUDY SITE MANAGER
Present Bayer HealthCare Pharmaceuticals
Department of Monitoring and Study Management
Fairfield, NJ
Along with full monitor site workload, involved in managing recruitment database, presenting at semi-annual training meetings, update SOP-based CRA electronic manual, coordinate and preside over study team meetings, study website maintenance, FAQ logs, country site newsletters, vendor liaison, and lead for database reconciliation.
May 2008 to HOMEBASED / DECENTRALIZED CRA II
May 2010 Bayer HealthCare Pharmaceuticals
Department of Monitoring and Study Management
Fairfield, NJ
Monitor for phase II and III clinical trials of investigational drugs. Responsible for complete site management, monitoring, providing data quality assurance, and assisting in study administration. Maintain monitor reports and scheduling. Generate, track and resolve queries. Communicate with clients, investigators and vendors. Prepare and maintain regulatory documents.
August 2006 to HOMEBASED / DECENTRALIZED CRA II
May 2008 PAREXEL International
Clinical Operations Group
Waltham, MA
Monitor for phase II and III clinical trials of investigational drugs. Responsible for complete site management, monitoring, providing data quality assurance, and assisting in study administration. Maintain monitor reports and scheduling. Generate, track and resolve queries. Communicate with clients, investigators and vendors. Prepare and maintain regulatory documents. Aid in the preparation of submission of regulatory documents to IRBs.
January 2005 to SENIOR CLINICAL SCIENTIST I
August 2006 Wyeth Research
Medical Research Group
Womens Health Department
Collegeville, PA
Member of large team for active, long term Ph III study. Responsibilities
include site management, SAE processing and narratives, ongoing data review. Lead for one of the primary endpoint data, requiring review and collection of documents for worldwide cases and addressing all related issues.
February 2004 to CLINICAL TRIAL MANAGER II
January 2005 Wyeth Research
Clinical Trial Operations
Infectious Disease Department
Collegeville, PA
Co-Lead on active Ph III study. Primary duties include Trip Report Review, coordination of Latin America site grant payments, liaison with Latin America Wyeth monitors, maintaining IND filings and regulatory documents.
January 2004 to TRIAL SUPPORT SPECIALIST II
February 2004 Wyeth Research
Clinical Trial Operations
Infectious Disease Department
Collegeville, PA
Assist Clinical Trial Manager on active Ph III study.
Stephen Mekonis CV
Page 2
July 2002 to CLINICAL SCIENTIST II
December 2003 Wyeth Research
Clinical Research and Development
Infectious Disease Department
Collegeville, PA
Assist Study Team Lead with IND study responsibilities.
Duties include site recruitment, management of CROs/vendors,
Serious Adverse Event processing, maintenance of regulatory documents, IND filings to the FDA, trip report processing and reviewing, clinical data review, informed consent review and approval,
coordination of test articles and clinical supplies to sites, investigator
payments, involvement with and training of international affiliates.
April 1999 to CLINICAL RESEARCH ASSOCIATE II
July 2002 Covance Periapproval Services Inc.
Medical Research Group
Radnor, PA
Involved with study management, internal leadership and communication of project. Provide coaching, training and leadership for CRAs and maintain quality within project. Communicate with the client as appropriate. Review and approve study trip and expense reports. Oversee completion of study related documents. Monitor project progress.
February 1998 to CLINICAL RESEARCH ASSOCIATE I
April 1999 Covance Periapproval Services Inc.
Medical Research Group
Radnor, PA
Monitor phase III and phase IV clinical trials of investigational and approved drugs.
Stephen Mekonis CV
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RESEARCH EXPERIENCE:
May 2010 to present
Site Manager
Monitor of multiple study, multi-site indications including several for MRI contrast medium, womens health / contraception, and pulmonary hypertension,
May 2008 to May 2010
Monitor of multiple study, multi-site indications including MRI contrast medium, VTE prophylaxis, and hemophilia maintenance.
August 2006 to May 2008
Clinical Research Associate
Clinical Scientist
Multicenter, randomized, open label and double-blind, Phase II and III studies, assessing the safety and efficacy of test article on polycystic kidney disease patients.
January 2005 to August 2006
Clinical Scientist
Multicenter, randomized, double-blind, Phase III study, assessing the efficacy of test article on fracture incidence reduction in osteoporotic postmenopausal patients.
July 2002 to January 2005
Clinical Scientist / Trial Specialist / Trial Manager
Multicenter, randomized, double-blind, Phase III study, assessing the efficacy of test article on intra-abdominal infections in hospitalized patients.
June 2004 to January 2005
Trial Manager
Single Center, randomized, double-blind, Phase II study, assessing tolerability, pharmacokinetic, and efficacy of test article in subjects with river blindness infection.
November 1999 to July 2002
Lead Monitor
Open label, pilot study (Phase IV), assessing conversion to study medication in maintenance renal transplant patients.
Stephen Mekonis CV
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RESEARCH EXPERIENCE (CONTINUED):
July 1999 to November 1999
Monitor
Multicenter, randomized, double-blind, Phase II
study assessing the effect of study compound in urinary
incontinence patients.
September 1998 to July 1999
Monitor
Multicenter, parallel, controlled, one year retro-spective post marketing study assessing both cardiovascular imaging and clinical findings in obese patients.
February 1998 to August 1998
Monitor
Multicenter, parallel, control-matched post marketing study, assessing both cardiovascular imaging and clinical findings in obese patients.
COMPUTER SKILLS:
Windows 7, Outlook, Excel, PowerPoint, Outlook, as well as several internal research databases, and EDC systems (InForm, RAVE)
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