Responsible for processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials. Responsible for the case management lifecycle from receipt through case completion. Responsible to liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related case processing tasks as required.

· Project management of grant funded and pharmaceutical sponsored clinical trials and investigator-initiated research; Project lead for all aspects of study coordination from start up to study close out in compliance with ICH, GCP regulations and applicable SOPs; Coordinate and participate in site initiation visits and closures; Coordinate and participate in monitor visits.· Comprehensive data management and data quality control for industry-sponsored and investigator-initiated studies involving various database systems, including Medidata Rave, WebDCU, REDCap, and Excel; Experience developing case report forms and building reports. · Maintain all regulatory documents and Trial Master File; Develop/edit informed consent forms, study process checklists and other study documents; Submit IRB applications, continuing reviews, adverse events, and protocol deviations.· Screen and identify potential research subjects; Obtain informed consent and enroll subjects for clinical trials; Administer investigational drugs; Monitor for and report adverse events. · Extensive experience submitting Serious Adverse Event packages to the sponsor and to the IRB; Maintain source documentation and case report forms; Complete data verification forms/respond to queries. · Educate multidisciplinary staff members on study protocols, procedures and responsibilities; Mentor junior staff on all aspects of clinical trial site coordination, electronic databases and regulatory maintenance; Mentor and supervise undergraduate students on various clinical research projects. · Assist with development, feasibility, implementation, and abstract/manuscript submission of a research protocol by an investigator, which may include residents, physicians, or other parties.· Daily use of MS Office Applications and Adobe Pro.· Lead quality assurance projects for the department.· Assist with development of payment milestones in electronic tracking system.

· Admission nurse, circulating nurse and scrub nurse responsibilities utilizing electronic medical records within an ambulatory surgery center including several specialties: Gynecology, General Surgery, ENT, Orthopedics, Plastics, Vascular, Infectious Disease, Pulmonology, and Urology. · Surgical procedures and outpatient treatments include those for ovarian, uterine, cervical, vaginal, breast, prostate, bladder, skin, thyroid, and lung cancers.

· Pre/post-op nurse, circulating nurse, and scrub nurse responsibilities within an ambulatory surgery center specializing in ophthalmology.· Extended responsibilities encompass interacting with patients to schedule surgery including explaining risks and benefits of surgery and obtaining informed consent.· Assisted in ophthalmology office: record patient histories, assist Doctor, coordinate staff.

· Assist with dermatologic treatments and surgical procedures for skin cancers and other skin diseases. · Review discharge instructions and treatment plan with patients.· Coordinate care as needed.