• Writing, editing, QC, and/or medical review of drug safety documents, including patient narratives and aggregate reports while following client-specified templates and clinical style guides • Review and summarize relevant medical information from source documents generated from clinical and safety databases in the form of SAS data, Excel files, CIOMS or MedWatch forms, and adverse event or serious adverse event forms • Frequent project lead experience for a variety of safety documents, including periodic and developmental safety update reports and patient narrative projects• Experience writing investigator brochures, benefit-risk documents, and general investigational plans• QC or document quality review of clinical and non-clinical documents as assigned• Work both independently and on a team, interacting with colleagues, project leads, and supervisor who may be located in any of the global offices • Maintained an additional role as liaison for the Synchrogenix Philippines office by collaborating with colleagues and team leads to coordinate and resource daily assignments

• Coordinate the conduct of Phase I-IV clinical oncology trials primarily for hematologic, lung, and head and neck malignancies• Consent and screen patients for clinical trials and provide patient and family education about the protocols and study drug side effects• Document all patient interactions in EMR system (EPIC)• Provide oversight of administration of or dispense study drugs as appropriate• Conduct nursing assessments, pharmacokinetic sampling, electrocardiogram, and vital sign monitoring as per protocol; perform medication reconciliation; assess patient status; and monitor treatment side effects• Coordinate patient visits, scans, and other clinical testing as per protocol and additional visits for standard of care or symptom management as needed• Triage medical issues arising from study treatment or disease • Follow Good Clinical Practices and adhere to all University of Pennsylvania, Informed Consent Form, and FDA guidelines• Demonstrate vigilance in patient safety, protocol compliance, and data quality• Ability to interact with faculty and staff of all levels and maintain close communication regarding protocol requirements and patient safety• Interpret study budgets to ensure appropriate ordering and billing of study-related procedures • Prepare serious adverse event reports and ensure timely submission of initial and follow up reports

• Facilitate operation of clinical oncology trials, primarily Phase I, by acting as liaison between pharmaceutical sponsor and study site• Coordinate patient care and scheduling per protocol requirements• Ensure patient eligibility prior to study enrollment and throughout trial• Create and prepare chemotherapy orders and scheduling templates• Timely submission of study-related documents per Regulatory requirements • Extensive daily interaction with patients regarding study requirements including ongoing toxicity assessments, including in-person and phone triage assessments• Extensive patient education including protocol requirements and symptom control• Successful coordination of up to 12 active trials at any given time• In-service Clinical Research Unit RNs as necessary on new protocols and protocol amendments• Participate in orientation of new employees• Responsible for timely case report form completion.• Followed FDA guidelines for reporting adverse events and serious adverse events