- 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
- 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.
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Oncology Clinical Site Monitor II
2 days ago
Atrium Health Charlotte, United StatesOverview 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 w ...
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Atrium Health Charlotte, NC, United StatesJob 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 mi ...
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IT Operations Manager
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Sapphire Solutions Charlotte, United States(Junior) IT Operations Manager (w/m/d) Your challenges with us In the middle of it all: As a (Junior) IT Operations Manager (w/m/d), you are the central point of contact for IT questions from your internal colleagues. Responsibility: You are responsible for analyzing and resolvin ...
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Compumedics Charlotte, United StatesBASED IN- Charlotte, NC, USA_ · - EMPLOYMENT TYPE - Full time_ · **Overview**: · **Job Summary**: · Compumedics is currently searching for a **Clinical Application Support Analyst** based in Charlotte, North Carolina to join our Global Support Team. Reporting to the U.S. Service ...
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DraftPros LLC Charlotte, United StatesPlant Contract Inspector · **Responsibilities and Duties** · - Conduct inspections of outside plant installations to ensure compliance with company standards and industry regulations. · - Evaluate contractor workmanship and adherence to specifications during installation and main ...
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Kuester Management Group Charlotte, United StatesStarting in 1975 and building its reputation on a strongly held family foundation, Kuester Management Group began its endeavor as one of the Carolinas' leading association management companies in 2001. We provide a full range of community management services; working alongside bu ...
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Charlotte Community Health Clinic Charlotte, United States**Job Summary**: · The RN Care Manager addresses the needs of the population served by assessing, planning, implementing, coordinating, monitoring, and evaluating the options and services required and using communication and available resources to promote quality, cost-effective ...
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HMSHost Charlotte, United StatesHMSHost at Charlotte Douglas International Airport · HMSHost · 5501 Josh Birmingham Parkway · Charlotte, NC 28208 · **With a career at HMSHost, you really benefit We offer**: · - Health, dental and vision insurance · - Generous paid time off (vacation, flex or sick) · - Holiday p ...
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Security Professionals
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Allied Universal® Charlotte, United StatesSecurity Professionals - Downtown High Rise · **Overview**: · Allied Universal, North America's leading security and facility services company, provides rewarding careers that give you a sense of purpose. While working in a dynamic, diverse and inclusive workplace, you will be pa ...
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CBRE Charlotte, United States**Area Maintenance Manager** · **Job ID** · **Posted** · - 16-May-2024**Service line** · - GWS Segment**Role type** · - Full-time**Areas of Interest** · Engineering/Maintenance · **Location(s)** · Charlotte - North Carolina - United States of America · At **CBRE Global Workplace ...
Oncology Clinical Site Monitor II - Charlotte, United States - Atrium Health
Description
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
Physical Requirements
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.
Oncology Clinical Site Monitor II professionals in Charlotte
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Myieh Leggette
Certified Clinical Trial Assistant