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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