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Posted: Sunday, July 23, 2017 8:59 AM

Your challenge The senior clinical research associate performs and coordinates all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and Philips standard operating procedures. A clinical research associate monitors the clinical study and ensures that investigators follow the clinical trial protocol at all times to obtain high quality integrity data. The clinical research associate leads or provides oversight to third party CRAs involved with site monitoring. The Senior CRA will coordinate clinical study activities including development of protocols, preparation of informed consents, investigator brochures, sections of regulatory submissions, Case Report Forms and other study materials. Oversee internal and contract monitors, review clinical data, complete trend analysis, communicate study progress, risk, and best practices to study team. Coordinate and communicates with universities, contract research organizations, private practices, institutional review boards, and other functional groups engaged in the conduct of clinical studies. Your responsibilities · Responsible for data monitoring and study site management · Responsible for overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication · Work according to Good Clinical Practice, rules and regulations and internal procedures • Contribute to protocol development and study related documents such as informed consent related to monitoring activities • Support site identification, selection, i.e. recruitment & qualification, and initiation • Develop the monitoring plan for clinical studies • Assure study site management; conduct data and study site monitoring activities for clinical studies, assure investigators and study site personnel adhere to the study protocol, applicable local regulations, ICH/GCP guidelines and SOPs, monitor study progress, executes close out activities and authors related reports • Oversee and coordinate the work of third party CRAs (CRO-CRAs) • Ensure compliance to ICH/GCP/local regulations • Confirm and track that all key site personnel have project specific training • Responsible for study status reports, essential documents, and accurate study files • Support development of regulatory binders and investigational product shipments as applicable • Assist with resolution of investigational site/data queries • Liaise with project team members regarding study site issues • Travel to study sites for meetings and monitoring visits upon request (ca. 40% travel of which 10% international) • Other activities as assigned Your team As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. The Senior CRA is an integral member of the Clinical Affairs team within Clinical Operationsthat works closely with Clinical Study Managers. The position reports to Head, Global Clinical Operations. Clinical Affairs is responsible to develop and deliver clinical evidence globally to internal and external stakeholders to optimize product life-cycle, with flawless execution. The Clinical Operations group within Clinical Affairs provides leadership in design and execution of clinical programs to deliver high quality evidence to support Philips businesses – on time, within budget and in compliance to regulations and procedures. Clinical Operations supports all Philips Business Groups across a variety of indications, consumer products and medical devices, solutions and products. Our offer We welcome you to a challenging, dynamic and innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences: · A variable bonus based on both Philips results and personal performance · Extensive set of tools to drive your career, such as a personal development budget, free training and coaching · Solid company pension scheme and attractive collective health insurance package · Opportunity to buy Philips shares and products with discount · Healthy work-life balance We are looking for • Bachelor’s degree, in biological sciences or healthcare • At least 2 years related experience in (conducting) clinical trials (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry) • Good command of written and spoken English language • Excellent verbal and written communications skills • Excellent interpersonal and organizational skills • A pro-active, committed and motivated attitude • A demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations • Ability to work very accurate and thorough • Excellent record-keeping skills; good documentation practice • Ability to maintain excellent working relationships with a broad range of trial staff. • Ability to work well in a team environment but also independently without significant oversight • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines. • Flexibility in work hours and readiness to travel. “Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.”

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=216032&lang=en


• Location: Bothell, Seattle

• Post ID: 30158520 seattle
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