Kristin Schaefers's Email Addresses & Phone Numbers

* 10+ years of clinical trial experience, including 6 in project management * ACRP Certified Clinical Research Associate - CCRA * Research Coordinator experience - including development of investigator-initiated study * Proven experience with full trial management, monitoring and database development * Exceptional communication skills and influential management style - while maintaining team and company morale *...

* 10+ years of clinical trial experience, including 6 in project management * ACRP Certified Clinical Research Associate - CCRA * Research Coordinator experience - including development of investigator-initiated study * Proven experience with full trial management, monitoring and database development * Exceptional communication skills and influential management style - while maintaining team and company morale * Supervisor and Operational Management Team responsibilities Specialties: GCPs, ICH Guidelines, Monitoring, HIPAA, BIMO audits, Reimbursement, Database Development, Protocol Development, Informed Consent ProcessAssociate Director, Medical Devices @ * Member of the Executive Operations Management Team that oversees new business development, company growth and personnel initiatives * Direct supervisor for multiple personnel which includes career guidance, job growth and human resources support * On-site FDA audit (BIMO) support * Managed the process of site nomination, qualification, selection, and activation for multiple pre- and post- market device studies with various-sized sponsor companies (single-center, 10 subject EU studies to 50 center, 3000 subject IDE studies) * Creation of multiple protocols, case report forms, informed consents, clinical trial agreements, Events Adjudication and DSMB Manual of Operations, data management and monitoring plans * Data expertise encompassing query issuing/resolution, edit checks and database development * Extensive on-site monitoring experience * Led initiatives to foster execution of study objectives and exceed sponsor timelines * Provided on-site project support at a sponsor company for a 1300 subject FDA-regulated interventional cardiology study * Facilitated the expansion of company SOPs and creation of internal quality meetings From September 2006 to Present (9 years 3 months) Clinical Specialist @ * Directed electronic medical record implementation by managing front-line client support From 2006 to 2006 (less than a year) Research Assistant @ * Responsible for data collection and entry of sensitive information for longitudinal research project that has resulted in over 100 sociological publications * Collaborated with graduate students and professors with regards to effective strategies and solutions to overcome research obstacles that resulted in significant increased retention rate From 2005 to 2006 (1 year) Clinical Research Coordinator - Emergency Room @ * Identified potential research subjects utilizing a central admissions database for 10+ concurrent research protocols in an Emergency Department setting * Designed and executed a Pre-Hospital Study with two emergency room physicians for 42 undergraduate and medical students involving digital photography of accident scenes * Direct interaction through informed consent process, data collection and observation of patients and physicians for various research studies * Therapy areas included trauma, headache, sedation, cardiology, mental health, and sedation From May 2004 to September 2005 (1 year 5 months) BIS, Health Science, Child Psychology and Sociology: Law and Criminal Deviance @ University of Minnesota-Twin Cities Kristin Schaefers is skilled in: Protocol, HIPAA, Databases, Informed Consent, ICH guidelines, GCPs, Clinical Trials, Clinical Research, Medical Devices, Healthcare, Cardiology, Lifesciences, FDA, GCP, Sop, CTMS