Stephanie Schaeffer Email & Phone Number

Cincinnati, Oh, Us

Cincinnati Metropolitan Area, Ohio, United States

Site Operations Manager/Clinical Trial Manager, Blinded and Unblinded Trial Management, Visit Report ReviewerManaged the conduct of high-quality clinical trials in a blinded and unblinded capacity in a global scale according to ICH-GCP Guidelines, LEO Standard Operating Procedures, and other regulations and laws as applicable.• Leveraged experience in global unblinded trial management and all unblinded aspects of a clinical trial, and developed and maintained unblinded trial documents, monitored guidelines, visited report templates and planned and implemented new processes in an unblinded capacity. Liaised with blinded and unblinded project managers, local / country trial managers, and globally managed unblinded CRAs.• Demonstrated technical competence, plus assisted with user acceptance and implementation of standard electronic systems including Veeva Vault for quality documents / CTMS / TMF, electronic data capture (EDC), IRT, GCO reports, and other trial oversight dashboards.• Created and maintained appropriate national / global site management documents and other trial documents.• Managed and reported on the progress of the trial within the country / region, including communication and escalation of issues, including visit report review.• Identified and escalated process and site issues, providing intervention and feedback.• Liaised with the investigator and site staff to ensure open communication, learning, and motivation.• Conducted site engagement and oversight visits to build site and investigator relationships and supported the site CRA in quality and recruitment discussions.• Mentored, trained, and supported CRAs on monitoring, internal processes and procedures, and other duties.

National Clinical Trial Manager for US and Canada, Onboarding Trainer, Visit Report Reviewer and TrainerManaged the conduct of high-quality clinical trials in a blinded capacity in US and Canada and conducted site engagement and oversight visits to build site relationships and support the site CRA in quality and recruitment discussions while in the National Lead CRA / National Clinical Trial Manager role.• Monitored pre-study, initiation, routine, and close-out visits as an investigator for GCP compliance.• Recruited investigators and negotiated study budgets with investigator sites.• Obtained, reviewed, and processed regulatory and administrative documents from investigator sites, completed site payments, and reviewed site invoices against the Clinical Trial Agreement.• Reviewed and developed protocols and CRFs, and coordinated and presented at Investigators’ Meetings and Kick-Off Meetings.• Prepared and reviewed Serious Adverse Event (SAE) reports.• Crafted project management reports for clients and project personnel.• Resolved issues, questions, and requests for additional study supplies.• Reviewed and approved monitoring visit reports and follow-up letters, and trained visit report reviewers.• Reviewed and verified completed CRFs against source data, and issued and resolved queries of CRF data with study site personnel.• Reviewed Tables and Listings generated from study data.• Trained and mentored CRAs on monitoring, internal procedures, and query resolution, and other National Lead CRAs / National Clinical Trial Managers on visit report review and protocol deviation review.• Submitted essential / required documents to a central IRB or a country’s central Ethics Committee, and, if necessary, based on local requirements, the Competent Authority while under the National Lead CRA / National Clinical Trial Manager role.

Chicago, Illinois, United States

Senior CRA at LEO Pharma, CRA Mentor, Onboarding Trainer, Visit Report Reviewer and Trainer

Chicago, Illinois, United States

Dedicated to LEO Pharma, Inc.

Chicago, Il

Chicago, Il

Dedicated to Janssen and Astra Zeneca

Cincinnati, Ohio, United States

Division of Pulmonary Biology and Pulmonary Medicine

Bachelor Of Arts - Ba, Microbiology, General

Activities and Societies: Alpha Phi Omega Community Service Fraternity

Bachelor Of Arts, Microbiology

Activities and Societies: Alpha Phi Omega (Community Service Fraternity), Microbiology Club

Education record

Activities and Societies: National Honors Society