What are the responsibilities and job description for the Research Quality Auditor position at The Cancer & Hematology Centers?
Our Mission: At The Cancer & Hematology Centers we are dedicated to help, healing and hope for cancer patients and their families.
We provide our patients with advanced treatments, innovative research and, above all else, compassionate care. Our patients receive the most comprehensive, contemporary cancer care balanced with the compassion of a dedicated nursing and support staff. Treating cancer requires a team of committed and caring health care professionals working together to understand and address your needs. In addition to caring physicians, we have a full range of support staff available to assist you and your family, such as oncology-certified nurses, social workers, experienced lab and pharmacy personnel and a psychologist. Our focus is not just on healing but also on helping and offering hope. We know that being diagnosed with cancer is a life-changing event, and it takes a lot of adjustment to accept the emotional and physical realities of this disease. Our staff understands what you’re going through and can offer compassion and resources to help. To us, it’s important that healing isn't just centered on your disease site. Our cutting-edge cancer care is available close to home. Our medical staff have close ties to prominent hospitals and ongoing cancer research, and we bring those breakthrough advances to our regional centers to progress the level of care that is offered right here at home.
Why Join Us? We are looking for talented and high-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
Position Overview:
Under the direct supervision of the Research Quality Systems Manager (The CHC) the Research Quality Auditor will work collaboratively with all roles interacting with clinical trials to proactively ensure compliance with Good Clinical Practice, regulatory requirements, quality standards, and best practices throughout the lifecycle of clinical trials.
This schedule for this role is Monday to Friday working 7:30am to 5:00pm (40 hrs/wk).
Desired/Required Qualifications:
Education:
Bachelor’s degree or higher
Experience:
At least 1-2 year experience in a clinical research setting.
Demonstrated knowledge of current GCP, FDA regulations, ICH guidelines, and clinical trial quality assurance auditing techniques
Experience with clinical research FDA inspections highly preferred
Clinical trial quality or auditing experience highly preferred
Clinical study coordinator or clinical study sponsor experience preferred
Clinical oncology research preferred.
Primary Duties and Responsibilities
1. Provide expertise on current clinical trial regulations, requirements, and guidance from FDA, ICH, and other relevant regulatory authorities
2. Ensure compliance with all applicable federal, state, and institutional regulations governing research activities
3. Monitor changes in relevant regulations and implement updates to institutional policies and procedures accordingly
4. Guide staff on compliance-related matters and ensure adherence to established protocols
5. Lead a risk-based approach auditing program that ensures readiness for clinical trial audits at all levels: internal auditing, sponsor audits/oversight visits and FDA audits.
6. Lead support of regulatory inspections, sponsor/CRO audits, and inquiries by attending audits, hosting auditors, preparing documentation and addressing needs and findings
7. Document audit observations and prepare audit reports that detail nonconformities and findings and provide required actions for compliance and draft responses as applicable
8. Conduct routine internal quality assurance inspections to ensure compliance with GCP guidelines, regulatory requirements, site SOPs, and protocols.
9. Assist in the development, implementation, and maintenance of quality management systems to ensure compliance with regulatory requirements, industry standards, and organization policies
10. Track quality assurance findings and required actions through to resolution, including assisting in Corrective and Preventative Action Plan development and process improvement as applicable.
11. Identify potential risks and vulnerabilities in clinical research processes, systems, and procedures.
12. Participate in on-going process improvement activities and support the development of novel solutions for programmatic improvements.
13. Participate in the development and review of SOPs and work instructions to promote consistency and compliance in clinical research operations.
14. Assist in developing training materials and resources to enhance research staff understanding of practical application of regulatory requirements and best practices.
15. Communicate and interact with peers and other departments in a manner that is viewed as having a positive effect on patient services and The CHC staff morale.
16. Perform other duties as assigned, assist with assigned projects.
17. This employee has access to medical records. The parts of the medical record s/he needs to reference to perform his/her job are as follows: Lab Information System, Pharmacy Information System, Entire Chart/Electronic Medical Record (EMR), and internal and external clinical trial systems and portals.
18. Work collaboratively across department roles to review and document protocol deviations, assist with orientation of new team members, review findings and open action items in monitor visit confirmation and follow up letters; analyze these documents for patterns that may necessitate additional staff training.
