Overview
MRPC Make – Assembly & Test Jobs in Indianapolis, IN at Rolls-Royce
OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.
Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.
Job Description:
The 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. The Quality Control Specialist plays a vital role in ensuring the integrity, accuracy, and compliance of clinical trials with established regulations and standards.
The Quality Control Specialist 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. The Quality Control Specialist 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%
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Title: MRPC Make – Assembly & Test
Company: Rolls-Royce
Location: Indianapolis, IN
