Atrium Health Oncology Clinical Site Monitor II FT

Atrium Health - Charlotte, NC

Full-time - Mid Level

Charlotte, NC

Ambulatory Health Care Services

About the position

The Atrium Health Oncology Clinical Site Monitor II is a full-time position responsible for overseeing clinical trials to ensure compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves managing studies with minimal oversight, ensuring patient safety and well-being, and verifying the accuracy of clinical trial data. The Clinical Site Monitor will assist in the compilation of required documents for trial activation and will play a crucial role in training research staff. The position requires a proactive approach to analyzing supplies, procedures, and processes at medical sites, suggesting improvements as necessary. Additionally, the monitor will be responsible for monitoring informed consent and eligibility processes, ensuring that all aspects of the trials are conducted ethically and in accordance with established guidelines. The essential functions of this role include working independently and as part of a sponsor team, managing multiple complex trials, and performing site selection, interim, and close-out monitoring visits. The Clinical Site Monitor will review study drug storage, stability, inventory, and accountability, and will verify the destruction of unused products as required. Communication is key in this role, as findings must be reported in a timely manner to all sites according to the timelines defined in the LCI QA SOPs and guidelines. The monitor will also set up meetings to discuss concerns or findings with the site Principal Investigator (PI) or Sub-Investigator (SI). In addition to these responsibilities, the Clinical Site Monitor will develop Protocol Specific Monitoring Plans, collaborate with research sites to prepare for Co-operative Group audits and FDA inspections, and conduct training sessions on Quality Assurance and site expectations. Participation in protocol and electronic Case Report Form (eCRF) development, as well as the updating of LCI QA SOPs, guidelines, and processes, is also expected. This position primarily works in an office setting but may require mobility within the healthcare system and external locations involved in LCI clinical trials, some of which may be out of state.

Responsibilities

• 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.
• Verify 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.
• Handle several priorities within multiple, complex trials.
• Perform site selection, interim and close-out monitoring visits.
• 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 to communicate concerns/findings to the site PI/SI.
• Develop Protocol Specific Monitoring Plans.
• Independently collaborate with research sites to prepare 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.

Requirements

• 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.
• At least 2 years auditing/monitoring experience preferred.
• Familiarity with current Good Clinical practices and the Code of Federal Regulations.
• Excellent written and verbal skills as well as excellent organizational and interpersonal skills.
• Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred.

Nice-to-haves

• Experience with electronic Case Report Forms (eCRF).
• Knowledge of Co-operative Group audits and FDA inspection processes.