Research Quality Control Specialist Oncology

Banner Health CorporatePhoenix, AZ
2d

About The Position

Banner MD Anderson is seeking a detail-driven Oncology Research Quality Control (QC) Specialist to lead efforts in ensuring the integrity and compliance of clinical research trials. This critical role focuses on proactive, routine, and risk-based reviews of clinical trial documentation (ICFs, eligibility, source documents) to maintain high standards of quality, data integrity, and safety. The QC Specialist will identify trends, gaps, and root causes, implementing Corrective and Preventive Actions (CAPAs) and ensure department's alignment with FDA, ICH-GCP, sponsor, and Banner research SOPs. You will partner with managers to reduce repeat deviations and errors, provide real-time education and feedback to coordinators, participate in onboarding and training initiatives, and lead inspection readiness efforts across sites. Candidates with experience as either oncology CRA or CRC are preferred. The position is full-time, Mon-Fri, 8am to 4:30pm. The primary home office for this position is located at 2946 E. Gateway Dr., Gilbert, AZ 85234. This role requires the ability to travel to multiple clinical sites to support operational needs. Specific locations include: Banner MD Anderson Cancer Center (BMDACC) at University 925 E. McDowell Rd., Phoenix, AZ 85006. BMDACC Boswell Campus 13041 N. Del Webb Blvd., Sun City, AZ 85351 Northern Colorado Sites (As Needed): Potential travel may be required to the following locations, subject to current travel restrictions and business necessity: BMDACC at North Colorado Medical Center 1801 16th St., Greeley, CO 80631. BMDACC at McKee Medical Center 2000 Boise Ave., Loveland, CO 80538. Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Research Health Institute (BSHRI) was founded in 1986. Our team is uniquely, passionately, and strategically committed to ending Alzheimer's disease and other neurodegenerative disorders without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. Banner Research is committed to improving people's lives through comprehensive patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's disease and other neurodegenerative disorders research and care. POSITION SUMMARY This position is responsible for leading the efforts to ensure the integrity and quality of clinical research trials. Responsible for reviewing and monitoring clinical research trials to ensure compliance with regulatory standards, protocols, and company policies. This role involves close collaboration with research teams, data management personnel, and regulatory bodies to maintain the highest standards of quality and accuracy in clinical trial data.

Requirements

  • Bachelor's degree in a related field (e.g., Life Sciences, Clinical Research, Quality Assurance).
  • Minimum of 3 years of experience in quality control or clinical research.
  • Strong understanding of clinical trial processes and regulatory requirements (e.g., FDA, ICH-GCP).
  • Excellent attention to detail and analytical skills.
  • Effective communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office Suite and clinical trial management systems.
  • Must be knowledgeable of data entry and computer programs associated with maintaining databases, spreadsheets, etc.

Nice To Haves

  • Prior experience in quality control or quality assurance in support of clinical trials.
  • Experience in clinical research specific to the relevant disease indication (e.g., Oncology, Neurology, or related fields) is highly preferred.
  • Additional related education and/or experience preferred.

Responsibilities

  • Conduct thorough reviews of clinical trial protocols, informed consent documents, and case report forms.
  • Monitor ongoing clinical trials to ensure adherence to study protocols and regulatory requirements.
  • Perform audits of clinical trial data to identify discrepancies and ensure data integrity.
  • Collaborate with research teams to resolve any issues related to trial conduct and data collection.
  • Prepare and present detailed reports on the findings of quality control reviews.
  • Assist in the development and implementation of quality control procedures and best practices.
  • Stay updated on industry regulations and guidelines to ensure compliance.
  • Provide training and support to research staff on quality control processes and standards.
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