1. Roger N. Hutson, bs<br />Hendersonville, TN<br />Phone: (615) 604-2457<br />RNHutson@bellsouth.net<br />~ Clinical Research Professional eager to contribute strong pharmaceutical and biotech research background <br />and well-demonstrated project leadership talents toward actively supporting the employer<br /> in achieving goals and objectives in project and/or resource management. ~<br />Profile <br />Provide leadership and to co-ordinate and manage the activities of multiple projects and project teams in a manner that ensures all timeframes and targets are met and that costs are kept under control.<br />Responsible for building, managing and developing site relationships at strategic levels<br />Advanced knowledge of ICH Guidelines, Good Clinical Practices, Medicare criteria and IRB policies and procedures to effectively expedite approval process to meet strict timelines.<br />Excellent academic credentials, reputation for unparalleled integrity and commitment to maintaining and enforcing confidentiality, and proven expertise in team leadership.<br />Comprehensive background conducting all types of on-site visits across all phases of research (Phase Ia, Ib, II, IIIa, IIIb, IV): 45 pre-studies, 70 site initiations, 250 interim monitoring and 55 close-outs.<br />Display a collaborative work approach and ability to drive cohesive efforts among all levels of a project team. <br />Therapeutic Areas:<br />Oncology (Growth Factors, Solid Tumors, Advanced Solid Tumors, Prostate Cancer) … Neurology (Migraines – adult and adolescent, Post-Herpetic Neuropathy, Ischemic Stroke) … Infectious Disease (HIV, CMV Retinitis, Hepatitis C, Nosocomial Pneumonia) … Musculo-Skeletal (Fibromyalgia; Bi-Lateral Meniscectomy, Chronic Low Back Pain) …Cardiovascular (Abdominal Aortic Aneurysm Reconstruction Surgery, Hyperlipidemia) … Dermatology (Pediatric Tinea Cruris, Pediatric Tinea Pedis, Pediatric Atopic Dermatitis) … Reproductive (Erectile Dysfunction, Menorrhagia)… Urology (Benign Prostatic Hypertrophy, Urinary Tract Infections, Transurethral Microwave Thermotherapy for Enlarged Prostate, Stress Urinary Incontinence) …Pulmonology (Chronic Obstructive Pulmonary Disease) …Gastro-Inestinal (Ulcerative Colitis, Opioid-Induced Bowel Dysfunction, Chronic Constipation, Irritable Bowel Syndrome) …Vaccines (Small Pox – Bio-Defense, Avian Bird Flu) …Other (Smoking Cessation) <br />Professional Experience<br />Vanderbilt-Ingram Cancer Center (VICC), Nashville, TN, 2009 to Present<br />Budget Compliance Officer<br />Apply significant organizational skills toward generating and processing clinical study budgets, insuring accuracy of budget templates against internal documents for compliance review.<br />Employ strong time management skills to successfully liaise with Vanderbilt’s Contracts Office, Compliance Department and Department of Finance to reconcile discrepancies between internal compliance document(s), final study budget, contract and/or Informed Consent Form (ICF).<br />INC Research, Raleigh, NC, 2008 - 2009<br />Clinical Team Leader (Home-Based)<br />Trained, motivated, supervised, directed and coached multiple personnel, emphasizing SOP compliance, productivity, accountability, and attentive client service.<br />Employed strong time management and communication skills to lead weekly project calls with project team members to review goals and objectives identified by upper management. <br />Planned and developed materials for web-based Investigator Meetings.<br />Exhibited keen multi-tasking capabilities in resource allocation, mentoring of associates with performance struggles, continuously establishing and monitoring quality and performance expectations of associates while effectively communicating to all regional associates the study timelines and expected compliance of project deliverables.<br />Spearheaded development of clinical monitoring plans that defined all monitoring requirements and were used by all monitoring associates assigned to that project team.<br />LBR Regulatory and Clinical Consulting Services, Crestview Hills, KY 2006 - 2008<br />Senior Lead Clinical Research Associate (Home-Based)<br />Employed strong analytical skills while conducting QA audits prior to sponsor auditing<br />Exhibited strong conflict resolution skills between site and study staff<br />Kforce, Tampa, FL, 2005 – 2006<br />Contract Clinical Research Site Manager (Home-Based)<br />Employed strong time management and communication skills as well as excellent multi-tasking capabilities while managing multiple Phase I oncology programs in addition to several Phase III studies<br />RNH Clinical Research Services, Gallatin, TN, 2004 - 2005<br />Clinical Research Consultant (Home-Based)<br />Became an entrepreneur and worked with one of the top five pharmaceutical companies<br />Successfully exceeded the client’s expectations by developing a tracking system for outstanding data queries prior to database lock; database lock occurred on time.<br />Study Manager and Study Site Liaison for approximately 60 sites to insure adequate data management resource utilization prior to database lock.<br />PPD, Wilmington, NC, 2000 - 2004<br />Senior Clinical Research Associate (Home-Based)<br />Managed and monitored multiple studies and indications.<br />Developed unique tracking system for tracking and reporting outstanding patient questionnaires/diaries to insure timely database lock.<br />Boston Scientific, Natick, MA, 2000 - 2000<br />Field Clinical Monitor (Home-Based)<br />Effectively initiated sites and conducted routine monitoring visits.<br />PPD, Wilmington, NC, 1999 - 2000<br />Senior Clinical Research Associate (Home-Based)<br />Effectively managed and monitored pediatric studies.<br />Covance, Nashville, TN, 1995 - 1999<br />Senior Clinical Research Associate <br />Employed strong communication and time management skills while acting as a Lead CRA, CRA Trainer, Project Manager and Project Director.<br />Gained insightful global experience as an International CRA.<br />ClinTrials, Nashville, TN, 1994 - 1995<br />Clinical Project Assistant<br />Successfully managed approximately 65 sites in-house.<br />Education<br />BS, Biology – Murray State University, Murray, KY<br />Computer / Software Skills <br />Microsoft Office Suite (Outlook, Excel, PowerPoint, Publisher, Word), Adobe Acrobat 9 Pro<br />