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1-3 years of experience in a relevant field supporting clinical trials through a clinical site, CRO or trial sponsor, clinical research coordinator Ability to travel 25%-50% of the time during peak periods Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research Excellent written and oral communication and presentation skills The ability to manage multiple priorities, while maintaining attention to detail is critical.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP.
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Sufficient understanding of FDA regulations and international regulatory requirements, clinical research methods, and biostatistics, as relevant to medical products. Assist Regulatory Affairs with mandated clinical reporting and ad-hoc device performance characteristics, including company Metrics.
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Undergraduate degree in Natural Science, Nursing, Clinical Research, Regulatory Affairs or Business or 4 years direct, relevant experience in clinical research or clinical trial-related work and GCP environment to provide a comparable background.
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Effectively and efficiently utilizes information systems/software to input, develop, track, trend, retrieve and report required data on-timeShows commitment to learning new knowledge and skills to enhance service, maintain competency and achieve organizational goals by incorporating research, current clinical literature and engaging subject matter experts.
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Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies.
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This individual ensures that contracts meet legal, regulatory, and institutional standards, ensuring a solid foundation for the successful execution of clinical trials. Responsible for managing the research contracts process and program and overseeing all aspects of contract negotiations with sponsors and stakeholders.
$58,979 - $98,298 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Conduct performance evaluations based on quantitative and qualitative data; evaluate clinical competencies of staff based on research-based practice guidelines; provide supervision to improve clinical outcomes such as enhancing client access, engagement and retention into treatment Caseload Management.
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Knowledge of ICH guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs is also a must. Paidion Research, Inc., a global pediatric clinical research organization, is part of Camargo Pharmaceutical Services.
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Minimum of 3 years of regulatory clinical trial experience within the clinical research environment. Researching regulatory issues pertaining to clinical trial protocols, consent forms, progress reports, IRB and drug approval processes to ensure adherence to regulations and guidelines.
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UPMC Hillman Cancer Center is currently hiring a regular full-time Regulatory Specialist to help support the Medical Oncology Clinical Research Services team located within the Hillman Cancer Center in Shadyside/Pittsburgh, PA. This role will support multiple disease center working Monday through Friday daylight hours.
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Description : GENERAL OVERVIEW:Manages research projects via study protocol, regulatory requirements and institutional policy; performs the nursing process for the study participants and performs clinical and administrative activities in support of evidence-based practice.
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