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Clinical Research Associate (CRA) or (Sr. CRA) - 1851059
Seattle, WA 98101 United States
Integrated Diagnostics is a venture-funded biotechnology company founded in 2009 that is focused on applying cutting-edge protein technologies to advance healthcare. The goal of the company is to develop molecular in vitro diagnostic (IVD) tests to interrogate biological circuits contributing to the pathogenesis of Alzheimer’s Disease and lung cancer. The company’s IVD product development effort is powered by proteomicsTM, integrating the knowledge of systems biology with the cutting-edge technology of multiple reaction monitoring mass spectrometry to identify and quantify blood proteins in diverse molecular pathways to discriminate between disease states.
Reporting to the Director of Clinical Operations, the Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr. CRA) coordinates research and administrative strategies for the management of clinical research. He/she is responsible for coordinating and monitoring clinical trials, both directly and indirectly with contract research organizations (CROs). The Sr/CRA will work as part of an interdisciplinary team and coordinate all activities required to initiate, monitor and complete clinical programs, both domestically and internationally.
Supervises and coordinates day-to-day activities of clinical sites and serve as the primary Sponsor contact with contract research organizations (CROs) and vendors related to assigned clinical projects.
Maintains all relevant site communications and both trial and site master files.
Participates in investigator site selection.
Conducts and coordinates activities associated with qualification, initiation, interim monitoring, study close out and audit visits as required.
Assists in development and review of protocol related documents, case report forms (CRFs) and monitoring plans.
Assists with the collaborative creation of study protocols, study reports, regulatory reports for discovery, verification, and validation studies, and support for ethical and regulatory submissions as required.
Communicates with internal departments as needed, including attending required meetings and following-up on action items.
Assists in development of departmental SOPs and personnel training programs.
Reviews study data and resolution of queries.
Travels to study sites based on project needs.
Performs other job related duties as assigned.
Education, training, experience:
BA/BS in a life science or medical discipline (nursing, pharmacy, etc.)
3-5 years of experience (5-8+ years for a Sr. CRA) at a Sponsor or CRO or equivalent combination of related education and experience.
Sr. CRA requires experience as a Study Lead and/or Study Manager.
Medical device or in vitro diagnostic (IVD) experience preferred.
Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations, GCP, and ICH guidelines is required.
Excellent planning, problem solving skills, and communication skills with the ability to communicate effectively with all levels of the organization.
Ability to travel up to 30%, based on project needs.
Proficiency with Office Suite and standard computer programs required.
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