Oncology Clinical Site Monitor II - Atrium Health Corporate FT Days

Atrium Health • Charlotte, NC, United States • $200k - $250k / year • 22h ago

Overview

Job Summary

Assist with the compilation of required documents for trial activation. Manage studies to ensure adherence to protocol, Good Clinical Practice (GCP) and regulations, ensuring patient safety, and well-being as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager. Assist in training of research staff. Analyze supplies, procedures, and processes of trials at medical sites and suggest options as needed. Monitor informed consent and eligibility processes.

Essential Functions

Work both independently and as part of a sponsor team commensurate with responsibilities of an Industry/CRO Clinical Trials level II monitor
Handle several priorities within multiple, complex trials
Perform site selection, interim and close-out monitoring visits
Manage studies to ensure adherence to protocol, GCP and regulations, ensuring patient safety, and well-being, as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager
Review study drug storage, stability, inventory, and accountability. Verify destruction of unused product as required
Perform essential Site Regulatory File review and reconciliation.
Communicate findings in a timely manner to all sites per timelines defined in LCI QA SOPs and guidelines. Set-up meetings, when necessary, to communicate concerns/findings to the site PI/SI
Develop Protocol Specific Monitoring Plans
Independently collaborate with research sites to prepare site for Co-operative Group audits and/or FDA Inspections
Conduct training/presentations to Clinical Trials Site on Quality Assurance and site expectations
Participate in Protocol and eCRF development
Participate in developing and updating LCI QA SOPs, guidelines and processes

Physical Requirements

Primarily works in an office setting
Requires full range of body motion; sitting for extensive periods of time; walking; standing, reading, and writing/keyboarding
Occasionally lifts and carries items weighing up to 35 pounds
Requires corrected vision and hearing within normal range
Must speak and read/write clearly in English
Must be able to be mobile within the entire healthcare system and external locations that participate in LCI clinical trials. Some of these locations maybe out of state.

Education, Experience and Certifications

Excellent written and verbal skills as well as excellent organizational and interpersonal skills. Be familiar with current Good Clinical practices and the Code of Federal Regulations. A Bachelor's degree in a healthcare or other scientific discipline required. At least 4 years’ experience in clinical research at a pharmaceutical company or a Contract Research Organization (CRO) required with at least 2 years auditing / monitoring experience preferred. Alternatively, an equivalent combination of education, training and experience will be considered. Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred.

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