Clinical Studies Specialist for Allergan, Inc. @ Advanced Clinical
A.A, Liberal Arts @
Santiago Canyon Community College
Assistant Project Manager @ From July 2015 to Present (4 months) Associate Live Study Manager @ From September 2014 to July 2015 (11 months) Clinical Studies Specialist for Allergan, Inc. @ • Contact investigative sites during site start-up activities. Responsible for collecting the required investigator and regulatory documents for a study and ensuring that the documents meet
Assistant Project Manager @ From July 2015 to Present (4 months) Associate Live Study Manager @ From September 2014 to July 2015 (11 months) Clinical Studies Specialist for Allergan, Inc. @ • Contact investigative sites during site start-up activities. Responsible for collecting the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations.
• Review and negotiate site contracts with applicable laws and regulations, Allergan's fall-back language, guidelines and defined processes.
• Provide accurate tracking and progress of site contracts to project team and work closely with the operational teams for the timely delivery of fully executed site contracts within the study timelines.
• Liaise and communicate with Allergan corporate Legal, Clinical Operation and Finance departments when appropriate. From January 2014 to September 2014 (9 months) irvine, caClinical Project Analyst for Allergan, Inc. @ • Supervise the receipt and dissemination of study related regulatory documents and correspondence from assigned sites; screen documents for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness.
• Maintain ongoing communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines.
• Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; investigator and sub-investigator medical licenses; investigator and site correspondence.
• Review and negotiate confidentiality non-disclosure agreements in accordance with applicable laws and regulations, Allergan's fall-back language, guidelines and defined processes. From April 2013 to December 2013 (9 months) Irvine, CAClinical Research Analyst @ • Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provide training on completion of the CRF; monitoring activities and study close-out activities.
• Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perform validation of source documentation. Prepare monitoring reports and letters in a timely manner.
• Document accountability, stability and storage conditions of clinical trial materials. Perform investigational product inventory. Ensure return of unused materials to designated location or verified destruction. From April 2011 to April 2013 (2 years 1 month) Rancho Cucamonga, CAPharmacy Technician @ • Fill daily drug orders accurately and efficiently in a timely manner to keep scheduled promise times.
• Answer incoming calls and complete outbound calls to patients, physicians and pharmacists while ensuring a high level of customer service and maximizing productivity.
• Assume additional responsibilities relating to third party insurance billing and shipping and receiving. From March 2009 to April 2011 (2 years 2 months) Irvine, CA
B.S., Biology @ University of California, Santa Barbara From 2006 to 2009 A.A, Liberal Arts @ Santiago Canyon Community College From 2003 to 2005 Michelle Hingst is skilled in: HIPAA, Clinical Research, Clinical Trials, Healthcare, Clinical Monitoring, Drug Accountability, Site Initiation, CRFs, Query Resolution, Clinical Site Monitoring, Clinical Research..., ICFs, Clinical Protocols, Pharmaceutical Industry, GCP, Validation
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