Certificate, Clinical Trial Management @
Exceptionally driven clinical research professional with Ph.D. in Biochemistry and over ten years of clinical trial experience. Background includes study management, investigator recruitment, protocol development, and solid knowledge of FDA regulations. Adept at managing multiple projects and meeting aggressive deadlines. Skilled communicator with demonstrated ability to compile, translate, and present complex scientific and clinical data to diverse
Exceptionally driven clinical research professional with Ph.D. in Biochemistry and over ten years of clinical trial experience. Background includes study management, investigator recruitment, protocol development, and solid knowledge of FDA regulations. Adept at managing multiple projects and meeting aggressive deadlines. Skilled communicator with demonstrated ability to compile, translate, and present complex scientific and clinical data to diverse audiences.
Therapeutic expertise includes oncology, women’s health, ophthalmology, and GI.
Instrumentation expertise includes HPLC, LC-MS, SPR, ITC, MALDI, small-molecule research, and RNA research.
Teaching expertise includes organic chemistry, biochemistry, and graduate-level chemistry relating to clinical trial research.
Associate Director, Oncology Clinician @ From September 2014 to Present (1 year 4 months) Greater New York City AreaAdjunct Professor @ From February 2011 to Present (4 years 11 months) Past-Chair, Lehigh Valley Local Section @ From January 2012 to December 2014 (3 years) Clinical Trial Lead @ Oncology Translational Medicine From April 2012 to September 2014 (2 years 6 months) Clinical Scientist @ Responsible for the overall coordination, management, and scientific merit of clinical trials from start-up through close-out activities. Experience with Phase I through post-marketing studies.
Consistently recommended to lead teams with challenging timelines, achieving success.
Achieved significant savings through Protocol Lead activities during interim analyses.
Primary Liaison to Clinical Research to guide genotyping strategy, genotype data collection, and implementation of scientific databases.
Key clinical resource bridging communication among financial, data management, trial management, and Investigator personnel, both internal and external.
Independently presented scientific and logistical information during site initiation visits and investigator meetings, both domestically and internationally.
Authoring responsibilities achieved on, or prior to, target deadlines. From November 1999 to March 2012 (12 years 5 months) GMP Quality Associate @ Independently perform quality audits on outgoing clinical supplies, clinical packaging orders, and all relevant paperwork associated with clinical supplies.
Lead Auditor for IVRS UAT systems.
Completed PhD coursework, and passed cumulative examinations while providing full-time support to GMP-Quality customers From February 2004 to January 2009 (5 years) Staff Chemist @ Provided worldwide analytical, stability, and regulatory expertise to support the development and manufacture of Ophthalmics and Anti-viral products.
Developed and validated a reverse-phase HPLC chiral method for Timolol Maleate.
Developed and validated a new TLC identity method for COSOPT.
Responsible site liaison for MMD Argentina, successfully transferred over 25 analytical methods.
Chaired poster session for MMD Quality Forum 2000 (presented research poster); Co-chair for entire event in 2001. From November 1999 to April 2001 (1 year 6 months) Research Technician @ Synthesized and evaluated PVOH solutions and emulsions using standard quality testing procedures.
Promoted to interim laboratory supervisor within 18 months.
Published internal paper based on foam control agent analysis.
Developed and monitored a foam density test method; presented technique and initial findings at internal symposium.
Developed a new format for safe work practices.
Created and updated an on-line manual for all laboratory procedures.
Organized a laboratory tour for local high school students. From May 1994 to November 1999 (5 years 7 months)
PhD, Chemistry @ University of Delaware From 2004 to 2009 Certificate, Clinical Trial Management @ Temple University From 2001 to 2003 Masters, Chemistry @ Lehigh University From 1997 to 1999 BS and BA, Chemistry and Psychology @ Cedar Crest College From 1990 to 1995 Cocalico High SchoolCocalico High School Tara S. Baney, PhD is skilled in: Clinical Trials, Oncology, Chemistry, Clinical Research, HPLC, Clinical Development, GMP, Biochemistry, Lifesciences, Research, Pharmaceutical Industry, Drug Development, GCP, Laboratory, Drug Discovery
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