Dawn Serkin
Clinical Trial Management | Clinical Operations ClinSmart LLC
- Role
- Clinical Trial Management Clinical Operations at Clinsmart, Llc
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Dawn Serkin
Over my clinical research career, I have obtained a mix of Pharmaceutical and CRO clinical trial experience in all phases of the research process and previously held positions as a Certified Clinical Research Associate, Clinical Research Coordinator, pharmacovigilance Safety Associate and Clinical Data Associate.Additionally, I have held Nursing positions ranging in capacity from Head Nurse of Intensive Care/Coronary Care, Cardiovascular Clinical Nurse Specialist to Director of Nursing for a high-tech home care company.Therapeutic areas include Hematology/Oncology, Endocrine/Metabolic; Cardiovascular; Neurology; Respiratory/Pulmonary and Infectious Disease.Certifications include Regulatory Compliance and GCP; Clinical Research (Coordinator/CRA); Human Subjects Protection Certification; Informed Consent and Assent; Certification in Oncology from Fox Chase Cancer Center; Critical Care Nursing by Board Exam and Nursing Management from the University of Pennsylvania.
Experience
Clinical Trial Management Clinical Operations
Oct 2018 — Present · Philadelphia, PA, US
Responsible for the overall operational planning and activities for the implementation and conduct of clinical trials in compliance with ICH, GCP’s, SOPs, and local requirements. Accountable for milestone deliverables through interaction with the client and other functional departments related to management of trial activities. Responsible for investigator site management activities to ensure quality clinical data, subject safety, and adherence to applicable regulatory, protocol, and sponsor guidelines.
Education
Gwynedd Mercy University
Bachelor of Science Nursing (BScN), Research Nurse and Clinical Nursing
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