Nicole Rupprecht's Email Addresses & Phone Numbers

📖 Summary

Clinical Trial Operations Manager @ •Therapeutic areas: Pompe disease, ophthalmology From December 2013 to Present (2 years 1 month) Clinical Project Manager @ •Therapeutic areas included Hunter syndrome and Sanfilippo syndrome types A and B. From May 2011 to November 2013 (2 years 7 months) Street Outreach Counselor/Supervisor (Volunteer) @ •Helped homeless and street youth through outreach and mentoring. •Led weekly street outreach sessions in the Greater Boston area to establish relationships with the youth and to determine how best to help them transition from homelessness to independence. •Assisted with set up of Transitional House; acted as Resident Advisor. From October 2009 to December 2011 (2 years 3 months) Project Manager - TIMI Study Group @ •Managed implementation and conduct of large multinational clinical trial. •Coordinated the regulatory start-up process, including IRB submissions and contract/budget negotiations, and site approval procedures. •Designed and prepared presentations for Investigator Meetings, Webcasts, Monitor/Team Trainings, and Conferences. •Designed case report forms, site study aids, and patient recruitment materials. •Established clinical procedures and recruitment/retention strategies. From July 2010 to May 2011 (11 months) Clinical Project Associate/Clinical Trial Lead @ •Managed Phase I-IV clinical trials. •Provided clinical site support and negotiated contracts/budgets with clinical sites and vendors. •Appointed as champion to manage creation and implementation of Clinical Operation Instructions. •Training coordinator and Standard Operating Procedures (SOP) coordinator for Clinical Operations. From January 2010 to July 2010 (7 months) Sr. Clinical Research Associate @ •Took initiative to manage and coordinate clinical trials in the U.S. and Europe (in absence of Senior Manager and Clinical Project Manager). •Conducted literature reviews and consulted with surgeons for feasibility phase of projects. •Created and revised protocols, informed consent forms, case report forms, other supporting study documentation, and final clinical study reports. •Worked with surgeons to develop and coordinate the writing, review, and submission of manuscripts. •Managed, coordinated, and presented at Investigator Meetings, Study Close-Out Meetings, and Training Seminars. •Conducted internal site and sponsor audits and coordinated the conduct of internal audits by independent auditors. •Conducted qualification, initiation, interim monitoring, and close-out visits. From September 2007 to December 2009 (2 years 4 months) Clinical Research Associate @ •Traveled up to 85% to conduct site qualification, initiation, and interim monitoring visits. •Prepared IRB and other regulatory submissions. •Tracked flow of clinical data in a Clinical Trial Management System and Central Files. •Responsible for training new Clinical Research Associates and other team members. •Set up required databases and created site tracking reports to distribute to sponsors. •Drafted templates of study documents and guidelines for clinical trials. •Designed budgets and administered finances throughout the project lifecycle. From June 2006 to September 2007 (1 year 4 months) Imaging Assistant @ •Coordinated study related activities of multiple protocols for Phase II, III, and IV clinical trials. •Acted as liaison with investigative sites, Clinical Research Associates/Monitors, and sponsors/vendors to resolve queries throughout the course of the study. •Used computer systems to convert medical image data to digital form. •Performed quality checks on study images (x-ray, MRI, CT), and maintained a database of medical images and associated results. From 2005 to 2006 (1 year) Master of Science (M.S.), Project Management (in progress) @ Boston University From 2012 to 2016 Physics, International Studies @ University of New Orleans From 2004 to 2005 Semester of Study Abroad @ Charles University in Prague From 2004 to 2004 Bachelor of Science (B.S.), Chemistry (ACS certified) @ Loyola University New Orleans From 2000 to 2004 Nicole Rupprecht is skilled in: Clinical Trials, CTMS, Clinical Research, Pharmaceutical Industry, Regulatory Submissions, Protocol, Clinical Study Design, IRB, GCP, Validation, CRO, Clinical Operations, Clinical Development, FDA, Clinical Monitoring