Stephanie A. Sherer, Rn, Rcp, Ccrp Email & Phone Number

• Provided triage, assessment and safe care to patients experiencing traumas, cardiac events, and other emergencies in a 40-bed, level 1 trauma emergency department• Implemented patient care through the administration of critical medications, IV infusions, and associated life-saving interventions and assessments

• Monitored research sites for compliance with GCP and ICH guidelines by leading remote and on-site study start-up and close-out visit activities• Developed, coordinated and executed site staff training activities; protocol amendments, electronic data management systems, and Sponsor SOPs• Served as a resource to site staff for clarification of protocol requirements• Managed and executed data query generation & resolution• Created and maintained site management and training documentation, visit audit reports, findings, follow-up letters, and corrective action plans• Assessed site recruitment, budgeting, contracts, and staff qualificat

• Led site management for ongoing studies - EDC, source document review• Managed inventory of laboratory supplies and research products• Collaborated with sponsor to initiate contracts (CTAs, CDAs), ISF, and staff training(Furloughed due to Covid)

• Extracted data from clinical trial protocols• Performed digitization of data to build SignalPath CTMS systems per protocol

• Spearheaded data management development for pilot sites and global operations• Performed screening, recruitment, enrollment, informed consent, and assessment of subjects from varying therapeutic areas; phase I-IV studies according to ICH, GCP, and FDA guidelines and SOPs • Developed source documents for study start up activities according to protocol• Coordinated study data management projects, activities and training• Managed inventory of clinical supplies & Investigational medicinal product (IP)• Processed AEs, SAEs, data and safety monitoring plan reports

• Performed screening, recruitment, enrollment, informed consent, and assessment of subjects from varying therapeutic areas; phase I-IV studies according to GCP, ICH, FDA guidelines and SOPs• Authored source documents for study start up activities according to protocol• Utilized electronic clinical research data management systems• Managed inventory of clinical supplies & Investigational medicinal product (IP)• Provided respiratory therapy (PRN) to hospitalized patients(CRC 2013-2015 | RRT 2012-2013)

• Analyzed clinical drug testing guidelines in order to train and present information to corporate leaders• Reviewed and approved drug labeling as well as legal, trade secret, production and marketing media for quality assurance• Authored technical regulatory responses to clients, customers, and government agencies• Led team as corporate liaison to Health Canada's Therapeutic Products Directorate (TPD); Responsible for drug product submissions to this government agency• Implemented technical information for the development of new product portfolios• Evaluated production and SOPs to ensure compliance with cGMP, GCP, NSF, FDA, and other federal guidelines

Graduate Certificate (Master'S Program), Clinical Research Management, 4.0

Bachelor Of Science, Medical Communications

Associate Of Applied Science, Nursing

Associate Of Applied Science, Respiratory Care Technology