Susan Magosin, MSN, RN
Clinical Trial Management @ Apellis Pharmaceuticals
About
Clinical operations professional with a demonstrated history of working in grant-funded, industry sponsored and investigator-initiated clinical research. Broad TA drug and device experience including oncology, ophthalmology, cardiothoracic surgery, neuroscience, gastroenterology, endocrinology, rare diseases & gene therapy. Breadth of career fully encompasses clinical trial operations (GCPs), study site management, clinical care and protection of human subjects, data management, and knowledge of design, analysis and regulation of clinical trials.
United States
Princeton Junction
Hospital & Health Care
Project Leadership, Document Review, Institutional Review Board (IRB), Trial Management, ICH, Clinical Study Design, Drug Development, Vendor Management, Written Communication, Clinical Research Associates, Collaborative Environment, Attention to Detail, Work Orders, Protocol Implementation, Communication, Contract Research Organization (CRO), Interpersonal Communication, Timelines, Group Communication, Clinical Operations
Experience

Community Member, Institutional Biosafety Committee (IBC)
Advarra (previously IRB Services)

Senior Clinical Research Associate
Greater St. Louis Area
• Served as the lead for an oncology compound, including co-monitoring • Recruited, initiated and monitored investigators in Missouri, Iowa, Nebraska, Kentucky, Ohio and Illinois • Monitored over 25 protocols across therapeutic areas including oncology, neuroscience and anti-infectives • Presented at investigators' meetings and team meetings on SOPs and adverse event reporting • Traveled approximately 80%, including domestic and international

Senior Site Manager / Trial Center Manager
Titusville, NJ
• Served as the U.S.-based Site Manager for two pivotal international pancreatic cancer trials (150 U.S. sites) • Partnered with two CROs as the monitoring of the pivotal trials was outsourced • Served as primary sponsor contact for all U.S. site questions, e.g. questions regarding subject eligibility and contracts • Reviewed and approved critical documents for drug release • Developed and reviewed patient consent forms • Managed follow-up to internal investigator audits • Conducted feasibility studies • Recruited and approved selection of investigators, negotiated site budgets and contracts, managed investigator payments • Reviewed protocols, CRFs and monitoring conventions • Presented at investigators' meetings and team meetings on SOPs and SAEs • Managed SAE receipt and processing to internal safety group, as well as obtain follow-up reports • Created data files to track SAEs • Reviewed CRA monitoring activities • Prepared Appendix I sections for NDA submission • Served as the primary site manager on in-house GI trials for chronic constipation • Resolved data queries and assisted in the preparation of analyses • Reviewed data tables and listings for interim analyses and study completion, including 3 successful and timely database locks • Conducted investigator assessment and initiation visits • Traveled approximately 30%, including domestic and international

Clinical Research Nurse
Philadelphia, PA
Managed an evaluation study of Familial Hypercholesterolemia, two Phase I gene therapy studies of a Urea Cycle Disorder and Cystic Fibrosis, and an immunology population study. Developed informed consent forms and other supporting documents, communicated with the IRBs, and evaluated and treated participants, many of whom resided outside of the U.S. Daily activities included supervising a staff of two and one undergraduate student volunteer, managing ten external clinical sites, and serving as the liaison for investigators.
Education
Susan Magosin, MSN, RN's Contact Information
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