Overview:
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Responsibilities:
* Participate in oversight of assignments, training, and management of central readers of cardiac imaging and ECG.
* Collaborate with Core Lab management on technical aspects of cardiac study assessments.
* Participate in sponsor site visits and audits related to cardiac assessments as requested.
* Participatie in training and subsequently demonstrating competency in the operation of independent central review of ECG and cardiac imaging for clinical trials.
* Review protocols, Image Review Charters and associated clinical and technical study documents as required.
* Complete source documents accurately and promptly, according to the specific protocol requirements and Medpace's SOPs.
* Blinded independent central review of ECG and cardiac imaging according to study endpoints as specified in clinical trial protocol, charter and according to GCP and standard Medpace SOPs.
* Participate in IntraReader and InterReader variability assessments.
* Participate in the development, review and evaluation of SOPs and study specific procedures.
Qualifications:
* Must have an M.D. and current medical licensure.
* Specialization in Cardiology required.
* Experience with ECG and most cardiac imaging modalities and expertise interpreting ECG, Holter-ECG and one or more cardiac imaging modality and therapeutic application.
* Experience with various ECG and cardiac image analysis and viewing software (including PACS).
* Experience working with computer software including Word, Excel, Access and Project preferred.
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