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As the primary resource for the protocol, the Senior Clinical Research Coordinator acts as a liaison between the patient, staff, investigator, collaborators, Institutional Review Board and sponsor.
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As the primary resource for the protocol, the Clinical Research Coordinator III acts as a liaison between the participants, investigators, Institutional Review Board and sponsor. The Clinical Research Coordinator III recruits, screens, enrolls and follows study participants, and perform the associated data collection, entry, and quality control activities, ensuring protocol compliance and close patient monitoring, and works independently in designing, coordinating, and implementing the assigned research project.
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Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
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Prepares study documentation in the event of a PMG, sponsor, or FDA audit and assists the auditor for the duration of the audit including correcting discrepancies in a timely manner. Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
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As CRA, you will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials.
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Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject’s primary care physician or specialist.
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The Athletic Business Manager is responsible for daily management of financial operations in the Athletic Department; assisting with budget and compliance with federal, state, college, and NCAA financial regulations; directly monitoring of corporate sponsor contracts; assisting with daily operation of the Athletic Business Office and coordination of general accounting activities.
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Manages fiscal integrity of assigned portfolio of grants and contracts by creating new grants, monitoring expenditures, managing receivables, collecting cash, projecting cash needs, accurately depositing cash receipts and reviewing for compliance with university, federal and other sponsor regulations.
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The CLM Credit Officer is a critical partner in the pre-screening of pipeline opportunities with Relationship Management, assessing credit appetite and identifying key issues, providing structuring input on financing options, underwriting, driving internal analytical work product and discussions on credit approvals, and maintain ongoing credit oversight of the lending portfolio relationships through quarterly and annual reviews along with covenant and other reporting monitoring, as applicable.
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As the primary resource for the protocols, the Research Coordinator will act as liaison between the investigators, primary care providers, the institutional review board (IRB) and the sponsor. Along with the investigator, the Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study.
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Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
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3 years experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance or field monitoring. Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
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Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.
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Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelines. Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata, RAVE, IRIS, NSABP, GOG, RTOG etc.
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