Robert (Stephen) Wells, CCRP

*** ****** ****

Lexington, KY 40504

859-***-****

e-mail: abk4wb@r.postjobfree.com

QUALIFICATION HIGHLIGHTS

• Experience in research settings on multiple studies/sites including FDA and NIH grants

• Knowledgeable in many areas of research including ICH/GGP, IRB protocol submissions, on going

regulatory and safety reporting

• Proven project management abilities including ability to design, plan and implement ideas from conception

through completion; excellent at managing multiple responsibilities without compromise

• Accomplished communication skills both in one on one settings and addressing large audiences; proficient

in conducting training seminars

• Proven ability to translate technical information and provide training to staff, physicians and patients

• Committed to quality patient care; frequently recognized by physicians for attention to detail, patient

advocacy and decision making abilities

• Significant achievement in creating source documents incorporated and endorsed for use at multiple sites

• In depth understanding of multiple Electronic Data Capture systems (NDS R Dietetic Software, Cardiff

Teleform, PharmaEngine, REDCap)

• History of database development and maintenance using Access and SAS

CAREER HISTORY

Administrative Research Associate (Principal), 2010 to Present

University of Kentucky Department of Family and Community Medicine

• Project Lead for NIH R21 research project examining chronic low back pain treatments in rural and urban

areas

• Develop SOPs for progressive muscle relaxation and clinical massage therapy treatments

• Set up and maintenance of REDCap EDC for data management

• Involved in study start up (site selection, initiation and training)

• Track patient enrollment and complete NCCAM status update reports to OCRA

• Responsible for study coordination; including recruitment, enrollment and monitoring

• Manage grant application and monitor grant expenses and budget

• Prepare financial documents for payment according to university guidelines

• Travel to participating study sites within Central Kentucky

• Grant writing and development of further research projects in the Department of Family and Community

Medicine

Clinical Research Monitor, 2006 to 2010

Kentucky Neurosciences Institute, University of Kentucky

• Monitored sites for protocol and documentation compliance according to monitoring plan

• Facilitated preparation and collection of site level documents, including Query Resolution

• Executed site initiation and training activities

• Assured compliance for GCP and SOP guidelines for NIH sponsored study.

• Developed study manual, protocol, newsletters, and PI meetings.

• Managed and organized all IRB correspondence including applications, continuing reviews, amendments,

and adverse event reporting

• Constructed study document templates including source documents, CRFs, ICFs, monitoring tools,

prescreening logs, amendment tables for protocol changes and tracking reports

• Executed site closeout activities

• Worked with Office of Sponsored Projects on budgeting details

• Interviewed potential personnel

Clinical Research Coordinator, 2005 to 2006

Department of Neurology, University of Kentucky

• Oversaw FDA and NIH approved projects

• Ensured subject enrollment met schedule deadlines

• Determined eligibility for enrollment based on the protocol and performed subject interviews

• Maintained source documents completed CRFs, including the completion and return of queries

• Reported serious adverse events according to IRB and sponsor guidelines

• Preparation and submission of IRB documents and regulatory documents for the sponsor

• Prepared full reviews and General Clinical Research Center applications, as well as consent forms

• Attended regular meetings with Principal Investigator to review weekly goals

• Created tracking system to manage patient appointments

• Maintained a professional/courteous relationship with patients

• Worked in laboratory completing various tasks with human specimen

OTHER EXPERIENCE

Sanders Brown Center on Aging – Data Systems Associate, 2003 to 2005

UK Wesley Foundation – Head Resident Advisor, 2002 to 2004

UK Wesley Foundation Board of Directors – Secretary, 2004 to Present

EDUCATIONAL ACHIEVEMENTS, CERTIFICATIONS & SKILLS

MPH (Projected Degree: August 2010) – College of Public Health

University of Kentucky – Lexington, Kentucky

BA – Psychology, College of Arts and Sciences

University of Kentucky – Lexington, Kentucky

Certified Clinical Research Professional (SoCRA)

Certificate for Completion of University of Kentucky UAP Phlebotomy

CPR and AED for the Community and Workplace (AS&H Institute)

Certification of HIPAA Research Education (UK – ORI)

Human Research Curriculum (CITI)

Bloodborne Pathogens Training Program (UK – OH&S)

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