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Exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork regulatory paperwork, consenting and interacting with study subjects, strict protocol adherence and archiving is preferred.
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Overview Position Summary: The Clinical Research Coordinator III, as a certified research professional, handles clinical trial administration for all protocol phases for the Leukemia and Lymphoma Disease department.
$61,360 - $110,572.8 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Performs Diagnostic Radiographic and CT Scan, MRI, or Mammography, according to department protocols, HFAP/TJC/local regulatory/CMS, State and Federal Regulations. Wears radiation (dosimetry) badge as per protocol.
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This role sits within our Legal and Compliance team, a dedicated group of professionals who share a deep understanding of the law, a meticulous commitment to regulatory protocol, and a passion for facilitating business needs as they focus on their daily work.
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3+ years of Health Plan Compliance / Regulatory experience; 1+ year of Medical Coding experience. Strong familiarity with CMS and NYS audit protocol. In this role, the Claims Compliance Remediation Analyst will be responsible for supporting the Director of Claims Support to ensure claims rules, guidelines, documents, policies and procedures, reporting, job aides, training, and other key components are compliant with CMS and NYSDOH regulatory entities and maintained within a central repository.
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Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. Leads Implementation of statistical programming aspects of the protocol or clinical developmentprogram.
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Key Responsibilities Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, pati,ent safety and protocol/GCP/regulatory compliance. Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study.
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Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies.
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Leads end -to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs.
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To learn about our EVS team, click here: Education:High School Diploma or Equivalent (GED)- (Preferred)Experience:Certification(s) and License(s):Skills:Communication, Disease Management, Healthcare Regulatory Environment, Infection Control, Spill Management, TeamworkOUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, our Geisinger family and our communities.
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Receives surgical specimens following specimen protocol, and passes the specimen(s) off the sterile field to circulating nurse, verifying source of specimen. KEY SUCCESS FACTORSKnowledge of infection prevention and regulatory sterilization standards.
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Allen Bradley Controls Hardware and communication protocol experience desired. As a Associate Controls Engineer you will: implements and maintains plant equipment, systems and other fixed assets to a high standard of safety, quality, and productivity while maintaining compliance with all applicable regulatory requirements.
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Maintain regulatory documents; assist the Principal Investigator in the planning of protocol implementation and site initiation visits and routine monitoring of clinical studies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine.
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Knowledge of infection prevention and regulatory sterilization standards. Follows infection control policies, Association of perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice, Occupational Safety and Health Administration (OSHA) guidelines, and other regulatory requirements in order to assure a safe work environment for self, coworkers, and patients.
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Perform Quality Control and Quality assurance activities to verify and maintain accurate and complete protocol metadata in Clinical Research Systems. Facilitate regulatory review process by providing customer support and assist in training of Clinical Research Systems users.
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protocol regulatory jobs
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