Sarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies for patients. It is one of the largest clinical research programs, conducting community-based clinical trials in oncology and cardiology through affiliations with a network of more than 700 physicians in the United States and United Kingdom. Additionally, SCRI offers management, regulatory and other research support services to drug development sponsors and strategic investigator sites.
SCRI sponsors oncology clinical trials through its affiliation with clinical oncology practices. This work makes it possible for thousands of cancer patients to participate in research studies in the communities where they live.
SCRI provides research support services to oncologists, hematologists and drug development sponsors.
Responsibility for assisting with the development and implementation of Corporate Quality Assurance Program, managing and performing routine audits of investigative sites and internal processes.
- Monitors and modifies policy and procedure for quality management.
- Utilizes research audit tools that assess the quality indicators of the research process.
- Develops a calendar for monitoring quality indicators for all sites.
- Prioritizes quality indicators depending on severity/urgency.
- Identifies areas of deficiency in quality and reports those to Directors and other appropriate personnel.
- Assists in development and modification of GCP SOPs.
- Assists research staff in maintaining FDA compliance.
- Performs routine audits of research sites utilizing research audit tool to ensure quality.
- Reports audit findings to the appropriate leadership.
- Develops time line to ensure timely and appropriate follow-up in areas of deficiency.
- Communicates audit findings to the study PI.
- Maintains records of all internal and external audits and reports.
- Communicates with monitors and auditors of clinical trials as needed.
- Educates staff in quality improvement methods.
- Assists sites with responses to external audits and CAPA development.
- Ability to work within deadlines.
- Strong interpersonal, communication, and organizational skills a must.
- High level of proficiency with MS Office Knowledge of medical and clinical research terminology is required.
- Bachelor's or Master's degree in nursing, pharmacy or other science related field required.
- Three years experience in regulated clinical research required.
- Oncology nursing experience highly preferred.
- Quality assurance auditing experience preferred.
- Or equivalent experience
HCA Inc - 9 months ago