Description
Summary * Highly qualified clinical research professional with over 17 years' experience, including Phase I-IV domestic and international studies (including EU, Eastern EU, South America, Asia, and Canada) in a wide range of therapeutic areas. * Experienced in all stages of study development from start up to close out with ability to view study progress by each data point or from a more global prospective. * Skilled at effective training and coaching of CRAs as well as site staff. Special expertise at building rapport with and motivating study team members and site staff. * Exceptionally motivated and flexible, with ability to prioritize and multi-task many project responsibilities while being solution focused. Clinical Research Experience Biotie Therapies, Clinical Research Consultant (Contract) September 2016 to January 2017 * Work directly with the Senior Director of Clinical Operations and the Global Clinical Lead to conduct the study start up activities for a 450 patient, 120 site, Global, Phase III, Parkinson's Disease study. * Successfully engaged the chosen CRO and vendors for the IRB, ECG Reader, Central Laboratories, and Rater Trainers for the PD, QOL, Movement, and behavior Scales. * Aided in the negotiation of all vendor budgets and authored the budget template for Investigational sites. * Reviewed and revised Study Protocols and authored Study Plans, ICF templates, Protocol training presentations, and study trackers, for the upcoming Phase III study. * Authored and spearheaded site feasibility efforts. * Aided in query resolution, Visit report review and the revision of the final newsletters for a phase II Parkinson's Disease study.
