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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
* 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
* 2+ years of relevant working experience in a clinical research setting at a CRO
* Or an R.N. or Bachelor's degree in biological sciences or other healthcare related field with/without related clinical research experience
* Working knowledge of the FDA CFRs and Good Clinical Practice Guidelines associated with CRA activities
* Must be proactive and able to work independently and with teams
* Excellent written and verbal communication skills
* Literacy in Microsoft Office (Word, Outlook, and Excel)
* Ability and willingness to travel possibly up to 50% of the time
Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email email@example.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
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