+ Provides clinical trials monitoring and follows established monitoring processes to support compliance with applicable regulations. + Provides monitoring support for all facets of clinical trials with special emphasis on institutional (investigator-initiated) and Cooperative Group sponsored trials. + Conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Emory University and applicable Food and Drug Administration (FDA) and other regulatory requirements. + Such activities may include: pre-study resource evaluations, monitoring of ongoing trials, and close-out monitoring of completed trials. + Conducts monitoring activities in accordance with established procedures. + Utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings. + Documents monitoring activities in writing, using appropriate report formats and communicates such findings to the appropriate parties (clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff.) + Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents. + Compares reported data with original source documents. Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines. + Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. + Verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed. + Verifies the following items for clinical trials: protocol compliance (i.e. subject recruitment and eligibility criteria and informed consent procedures); that only designated investigator(s) and/or appropriate clinical research staff are performing clinical trial functions; that regulatory compliance is being maintained (i.e. that investigators are providing and maintaining all study related documents as required.) + Promptly communicates any serious deficiencies noted during monitoring to the appropriate parties. + Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance. + Maintains a record of all correspondence, monitoring reports and other written documentation in accordance with operating procedures. + Participates in meetings and in-service training activities. + Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors. + Promotes a work environment that stresses and demonstrates confidential practices. + Follows Emory University and HIPPA compliance policies. Performs related responsibilities as required.
+ A registered nursing or a bachelor's degree in a related science field. + Three years of clinical research experience which includes one year of monitoring or administering complex clinical trials. + A sound knowledge of ICH and Food and Drug Administration's Good Clinical Practices regulations. + Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills. + A knowledge of basic computer programs, such as MSWord and Access. This position is intended for clinical researcher and all clinical training requirements must be tracked through Emory Healthcare under the CLINICAL RESEARCHER for individuals hired in this job classification. Apply Now
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_Exec.V.P. for Health Affairs_
_Winship Clinical Trials_
This position may involve the following Health and Safety issues:
Location : Name
_Emory Campus-Clifton Corridor_