10 ott - Bardi
Oxford Global Resources
Provide support to Clinical Affairs team to assure study site selection and conduct of the study by study sites in compliance with Good Clinical Practices, federal regulations, and Clinical Affairs SOPs through in-house and some on-site monitoring
Verifichi che le sue competenze e la sua esperienza corrispondano ai requisiti di questo ruolo, quindi si candidi con il suo CV qui sotto.
Conduct pre-study visits to assure the site has adequate facilities, staff, and subject population for conducting the study within established time frames
Coordinate the distribution of supplies to study sites and assure an adequate quantity of supplies on hand during the course of the study
Track distribution and return of all study materials and drug
Conduct site initiation in order to ensure that all elements are in place for performing the study according to protocol and in compliance with all applicable regulations and good clinical practice guidelines
Perform interim site monitoring visits and document findings in a monitoring report which will be completed in a timely manner
Perform close-out visits to all study sites
Assist in maintenance of Trial Master Files (TMFs)
Assist with preparation of informed consent (ICFs), case report forms (CRFs), study support documents for assigned studies
Review site generated ICFs for compliance with study protocol and federal regulations
Review and provide feedback to Clinical Trial Team Lead on data management documents
Review and provide feedback to Clinical Trial Team on pharmacovigilance plans for assigned studies
Evaluate and recommend selection of investigators/study sites
Train investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements
Ensure the collection, review, and updating of all essential documents defined by FDA regulations, company industry standards
Job Experience: 2+ years of relev
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