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Clinical Research Coordinator with extensive experience managing all aspects of clinical trials. Additional skills include retrospective chart reviews, grant writing, protocol development, and manuscript editing.
The Ohio State University College of Public Health - Columbus, Ohio
The Ohio State University School (now College) of Public Affairs - Columbus, OH
The University of Florida - Gainesville, Florida
Dean's List, 1 semester
Miami-Dade Community College - Miami, FL
GPA: Phi Theta Kappa, President's List Dean's List
Phi Theta Kappa, President's List (1 semester, Central Florida Community College)
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Cancer Treatment Centers Of America – Irving, TX,
Manage multicenter, industry sponsored Investigational Device Exemption (IDE) and post-market device studies, which have included Natural Orifice Translumenal Endoscopic Surgery (NOTES) Toolbox, LINX, EsophyX , and MUSE for gastroesophageal reflux disease (GERD), StomaphyX for weight regain post RNY, and near infrared cholangiography (NIRF-C) during cholecystectomy. Regulatory maintenance, including clinicaltrials.gov. Develop protocols, obtain IRB approval, and facilitate investigator initiated research. Negotiate budgets and assure research billing compliance. Trained research assistant (now promoted to research coordinator), coordinate and supervise yearly faculty/medical center mentored research projects. Our research accomplishments over the past two years include:
• 35 articles published in peer-reviewed journals,
• 24 peer-reviewed abstracts accepted and presented at national meetings
• ~$490,000 in external research funding
Albert Einstein College Of Medicine – Einstein/Resnick - Bronx, NY,
Coordinated multicenter, industry sponsored Investigational Device Exemption (IDE) and post-market device studies, including devices to treat intracranial aneurysms and carotid stenosis. Coordinated two NIH sponsored multi-center studies, Balloon Prophylaxis for Aneurysmal Vasospasm (BPAV, UC-Davis, lead site), and Investigational New Drug (IND) study prophylactic treatment with acetaminophen for vasospasm. Regulatory compliance for Humanitarian Use Devices (HUDs). Developed protocols, obtained IRB approval, and facilitated investigator initiated research. Negotiated budgets and assured research billing compliance. Obtained IRB approval for and maintained two prospective databases for arteriovenous malformations (AVMs) and intracranial aneurysms. Drafted, approved, and implemented Department of Neurosurgery Standard Operating Procedures (SOPs). Regulatory maintenance, including clinicaltrials.gov.
Harris County Dept Of Education – Houston, TX,
Coordinated all aspects of multicenter clinical trials, which included IDE studies: Onyx for Aneurysms and Onyx for AVMS, and the SECURITY carotid stent study. Coordinated multicenter NIH studies including the BPAV study (UC-Davis, lead site) and the Familial Intracranial Aneurysm (FIA) Study (University of Cincinnati, lead site). Regulatory maintenance for HUDs. Wrote an NIH/NINDS grant to obtain funding for a trigeminal neuralgia conference -- funding granted.
Warnermedia – VA, State,
Clinical administrative assistant to neurosurgeon, began coordinating clinical research.
Uniontown Hospital – Uniontown, PA,
Administrative assistant to neurosurgeon.
Two95 International Inc. – Greensboro, NC,
Administrative assistant to neurosurgeon.
The Neuroscience Research Foundation – City, STATE,
Coordinated the final year of the Medication Tracking and Review System (MTRS) project, funded by the Florida Developmental Disabilities Council (FDDC), including participant family/caregiver contact, data compilation, reporting, and presentation to the FDDC. Assisted principal investigator in developing and writing pharmacist guidelines. Performed literature searches and proofread manuscripts.
Member, Association of Clinical Research Professionals (ACRP) since 2003
ACRP Certified Clinical Research Coordinator since 2005
Member, American Public Health Association, includes Ohio Chapter since 2015
Journals
1. Beck C, Eakin J, Claire R, Renton D. Analysis of perioperative factors and cost comparison of single-incision and traditional multi-incision laparoscopic cholecystectomy. Surg Endosc 2012 Jul 18 [Epub ahead of print].
2. Demyttenaere SV, Bergman S, Pham T, Anderson J, Claire R, Melvin WS, Mikami DJ. Transoral incisionless fundoplication for gastroesophageal reflux disease in an unselected patient population. Surg Endosc 2009 24:854-848.
3. Wood D, Hornung R, Sauerbeck L, Brown R, Meissner I, Huston J, Foroud T, Broderick J, FIA Investigators. Age at intracranial aneurysm rupture among generations: Familial Intracranial Aneurysm Study. Neurology 2009 72:695-698.
4. Narula VK, Happel LC, Volt K, Bergman S, Roland JC, Claire R, Renton DB, Reavis KM< Needleman BJ, Mikami DJ, Ellison EC, Melvin WS, Hazey JW. Transgastric endoscopic peritoneoscopy does not require decontamination of the stomach in humans. Surg Endosc 2009 23:1331-1336.
5. Bergman S, Mikami DJ, Hazey JW, Roland JC, Claire R, Melvin WS. Endolumenal fundoplication with EsophyX: the initial North American experience. Surg Innov 2008 15:166-170.
6. Zwienenberg-Lee M, Hartman J, Rudisill N, Madden LK, Smith K, Eskridge J, Newell D, Verweij B, Bullock MR, Baker A, Coplin W, Mericle R, Dai J, Rocke D, Muizelaar JP, Balloon Prophylaxis for Aneurysmal Vasospasm (BPAV) Study Group. Effect of prophylactic transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with Fisher grade III subarachnoid hemorrhage: results of a phase II multicenter, randomized, clinical trial. Stroke 2008 39:1759-1765.
7. Reavey-Cantwell JF, Claire RR, Quisling RG, Mericle RA. The use of nitroglycerin for treatment of progressive moyamoya disease: A prospective pilot study of safety & efficacy. Journal of Pediatric Neurology 2007 5:101-109.
8. Velat GJ, Burry MV, Eskioglu E, Claire RR, Firment CS, Mericle RA. The use of abciximab in the treatment of acute cerebral thromboembolic events during neuroendovascular procedures. Surgical Neurology 2006 65:352-358, discussion 358-359.
Podium, National Meeting (co-author)
Demyttenaere SV, Bergman S, Winkleman BJ, Claire R, Mikami D, Needleman B. Gastric band manometry: are pressure measurements and the band pressure ratio useful? Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) April 22-25, 2009, Phoenix, Arizona.
Posters, National Meetings
1. Noria SF, Joyce C, Schick J, Abdel-Rasoul M , Claire R, Mikami DJ, Needleman BJ. Significance of Prolonged Tachycardia in the Immediate Post-Operative Period Following Roux-en-Y Gastric Bypass. The American Society of Metabolic and Bariatric Surgeons (ASMBS), June 17-22, 2012, San Diego, California.
2. Box D, Shah N, Mapa B, Nagel R, Way D, Claire R, Harzman A. Self-guided video review of performance does not improve learning in basic simulated tasks. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), March 30-April 2, 2011, San Antonio, Texas.
3. Roth JS, Hazey J, Davenport D, Narula V, Claire R, Banarjee A, Cavatassi W, Albright E. A prospective randomized trial comparing the Rebound hernia repair device and lightweight mesh for laparoscopic inguinal hernia: an interim analysis. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), March 30-April 2, 2011, San Antonio, Texas.
4. Demyttenaere SV, Bergman S, Anderson J, Claire R, Mikami DJ, Melvin WS. Transoral incisionless fundopliation for GERD: early North American results. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) April 22-25, 2009, Phoenix, Arizona. 4
Research billing, budget development, budget management, clinical research, clinical trials, databases, developmental disabilities, edit, case report form and survey development, grant writing, grants administration, IDE, IND, Humanitarian Use Device (HUD), regulatory compliance, marketing, policy analysis, publication, public health, research, specimen collection and processing
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School Attended
- The Ohio State University College of Public Health
- The Ohio State University School (now College) of Public Affairs
- The University of Florida
- Miami-Dade Community College
Job Titles Held:
- Clinical Research Coordinator
- Study Coordinator
- Coordinator, Clinical Programs
- Program Assistant
- Senior Secretary
- Secretary
- Project Manager
Degrees
- MPH
- MA
- BA
- AA
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