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:
* Perform clinical sample management, tissue processing, embedding/positioning, FFPE and cryogenic sectioning, and section processing though staining;
* Ensure validity of laboratory data reported;
* Develop methods for routine H&E/Trichrome stains as well as specific IHC/IFA/ISH protocols according to SOPs;
* Develop knowledge of clinical trial processes and procedures, including federal regulations, pre-analytical variables, and knowledge of disease processes;
* Participate in validation activities, experimental design, and instrument set-up;
* Contribute to maintaining a Quality environment and participate actively in SOP writing;
* Maintain overview of inventory and orders for tissue processing and staining platforms; and
* Comply with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
Qualifications:
* Active ASCP Board of Certification, e.g. HT(ASCP), HLT(ASCP);
* 2+ years of experience in a Histology laboratory performing tissue processing techniques including tissue embedding, sectioning, slide preparation, H&E staining, IHC/IFA/ISH processing, and process troubleshooting preferred but not required; and
* 1+ year of experience in a high throughput laboratory production environment using LIMS, Data Management systems, automatic tissue processing systems, and automated H&E/IHC stainers preferred but not required.
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