The Clinical Trial Monitor/Clinical Research Associate (Quality Control Specialist) will report to the Manager, Research Quality. This individual will collaborate with various OneOncology Research Network (OneR) teams and OneOncology network sites to support clinical research across the OneR network. This role plays a vital role in ensuring the integrity, accuracy, and compliance of clinical trials with established regulations and standards.

This role is responsible for evaluating clinical trial data and essential records for compliance with FDA regulations, Good Clinical Practice (GCP), quality standards, and best practices. This position ensures that established trial processes and protocols are adhered to, and data is collected and recorded accurately. This position requires a keen eye for detail and strong analytical skills to ensure data integrity is maintained. This role may also support general quality management initiatives and contribute to continuous improvement efforts to enhance the overall quality and integrity of research.

Key Responsibilities

• Conduct quality control (QC) activities on behalf of network sites

• Contribute to QC plans using a risk-based approach

• Review source records, data and regulatory documentation to ensure compliance with the study protocol, regulatory requirements, GCP guidelines, and site SOPs

• Document nonconformities and sites’ required actions for achieving compliance via standardized tools, ensuring this documentation is accurate, complete, and organized

• Track findings and required actions through resolution, working with sites to resolve nonconformities in a timely manner

• Prepare periodic reports and metrics to communicate status of QC activities and relevant outcomes to relevant stakeholders

• Identify areas for improvement in site-level and network-level processes and procedures

• Stay informed of current clinical trial regulations, requirements, and guidance from FDA, ICH, and other relevant regulatory authorities

• Support regulatory inspections, sponsor/CRO audits, and inquiries by preparing documentation and addressing findings as needed

• Participate in audit- and inspection-readiness activities

• Participate in the development and review of SOPs and work instructions to promote consistency and compliance in clinical research operations

• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

• Strong attention to detail

• Demonstrated analytical capabilities

• Excellent written and verbal communication skills

• Excellent interpersonal and organizational skills to create and maintain effective working relationships within OneR and with OneOncology practice partners

• Ability to initiate assigned tasks and work independently

• Ability to manage multiple projects in various stages and adhere to timelines

Qualifications

• Minimum of 2 years’ experience in clinical research; previous quality control and/or clinical trial monitoring experience preferred

• Working knowledge of applicable FDA regulations and GCP guidelines

• Proficiency in Microsoft Office applications

• Familiarity with electronic data capture (EDC) systems, electronic medical records (OncoEMR experience a plus), and electronic regulatory binders (Florence eBinders experience a plus)

• Bachelor’s degree required

• SOCRA or ACRP certification preferred

• Remote (U.S.-based) with potential for travel up to 25%

#LI-HH1

#LI-REMOTE