Oncology Clinical Site Monitor- Atrium Health Levine Cancer Bio Statistics Charlotte FT
Company: Atrium Health
Location: Charlotte
Posted on: April 28, 2024
Job Description:
Overview Job SummaryAssist 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 processesPhysical 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 CertificationsExcellent 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.
Keywords: Atrium Health, Huntersville , Oncology Clinical Site Monitor- Atrium Health Levine Cancer Bio Statistics Charlotte FT, Healthcare , Charlotte, North Carolina
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