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Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities.
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Excellent time management skills. Responsible for new research application (including study start-up processes and requirements) and submission of protocols with subsequent amendments. Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred.
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Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format. Provides new Protocols, Amendments and study status updates to necessary research staff for digitization/entry into CTMS.
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Duties involve animal husbandry, training, record keeping, and contributing to creating and presenting enrichment opportunities for animal ambassadors. Animal Ambassador Biologist (Full-Time.
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Submits amendments of protocols to Research Regulatory Affairs team and verifies the required corrections were inserted following the established procedures. Follows NCHS RI’s Standard Operating Procedures, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.
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Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
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Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budget, process improvement plans, and efficient timelines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols as appropriate.
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A High school diploma or GED supplemented by one (1) year full-time experience working as a Police or Public Safety Dispatcher. Do you possess at least one (1) year of full-time experience working as a Police or Public Safety Dispatcher.
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