The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development. The candidate will work across analytical functions, projects, and global sites.
The Clinical Research Associate (CRA), Oncology will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Successful candidates will be strategic, self-motivated, creative, efficient, and will have superior organizational and detail skills. This individual must have an interest in recruiting and research and have the ability to manage multiple projects and deadlines.
A highly motivated candidate is sought for a fellowship to conduct research on the pathogenesis of congenital heart diseases in the lab of Prof. Pirooz Eghtesady, MD, PhD, Division of Pediatric Cardiovascular Surgery, Department of Surgery at Washington University School of Medicine, St. Louis, MO.
The chosen candidate will be responsible for process development, scale-up, technology transfer, establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft-chews, non-sterile liquids and sterile inject (aseptic manufacturing) platforms, as well as collaborating and partnering with Manufacturing, Engineering, and Quality organizations.
Develop the health services research program. Facilitates and independently conducts academic/clinical research, supports research utilization in nursing/clinical practice and develops an ongoing strategic plan for academic/clinical research.
Standard molecular biology techniques such as molecular cloning, PCR, qRT-PCR, handling of retroviruses and lentiviruses, preparation and extraction of genomic DNA, RNA, Western blots, immunoprecipitation, in vitro binding assays, and ELISA.
In this role, the selected candidate will require track record in piezoelectric dispensing of proteins from borosilicate glass capillaries onto substrate for protein biochip fabrication, I.e. printing immobilized protein macroarrays on substrates.
In this role, you will perform complex statistical analysis of data collected and writes interpretative reports, verifies the correctness of the data submitted and makes recommendations based on these analyses.