Sanford Health Research Quality Specialist - Sanford Research in Sioux Falls, South Dakota
Job Title: Research Quality Specialist | Sanford Research | Sioux Falls
City: Sioux Falls
State: South Dakota
Department : BREAST HEALTH - INDIRECT
Job Schedule: Full Time
Hours Per Shift: 8 hr
Create and maintain investigational drugs and devices (IND/IDE) monitoring and quality assurance (QA) program to include policies and procedures manual and data collection forms used throughout monitoring and/or QA review of a clinical trial. Provides clinical trial monitoring for institutional investigator-initiated trials by following established monitoring processes to ensure compliance with federal regulations, study protocol and monitoring plan. Provides QA reviews and education for clinical research. Conducts a variety of QA activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Sanford policies, applicable Food and Drug Administration (FDA) regulations and other regulatory requirements. Utilizes appropriate QA and monitoring checklists and report templates to record and report findings. Documents QA and monitoring activities in writing, using appropriate report formats and communicates such findings to the appropriate parties: clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff. Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents. Compares reported data with original source documents. Reviews study related processes relative to applicable regulatory requirements, including the FDA's good clinical practice (GCP) regulations and departmental policies and procedures. Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. Verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed. Verifies the following items: protocol compliance, i.e. subject recruitment and eligibility criteria and informed consent procedures; study personnel, including principal investigator, are performing clinical trial functions as delegated and trained; regulatory compliance is maintained; investigators are providing and maintaining all study related documents as required. Promptly communicates any serious deficiencies noted during monitoring or QA review to the appropriate parties. Knowledge of effective collaboration techniques and ability to build networks with people from different countries and cultures, think and work with them to bring positive impact and flourishing business results. Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance. Maintains a record of all correspondence, monitoring reports or QA reports and other written documentation in accordance with operating procedures. Understanding of the necessity and value of accuracy and attention to detail; ability to process information with high levels of accuracy. Participates in meetings and in-service training activities. Maintains in strict confidence all information gathered or reviewed. Promotes a work environment that stresses and demonstrates confidential practices. Follows Sanford and health insurance portability and accountability act (HIPAA) compliance policies. Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills. Working knowledge and use of basic computer programs, such as MSWord and Excel. Sanford Research is a multi-site institution and occasional local travel between sites may be required.
Adjusts to new or changing assignments, processes, and people. Advises on federal, state or local laws and applies them to the organization. Delivers written and oral communication, responds to questions and concerns, and produce specific outcomes and impact. Demonstrates open, friendly, accepting, and supportive behaviors with team members. Follows standard operating procedures for the preparation, undertaking and closure of clinical research. Leads in developing and monitoring key performance and availability factors. Participates in clinical research activities according to study protocols. Presents a professional image, especially when dealing with customers. Recognizes changing demands and priorities; validates changes with management. Responds to day-to-day operational priorities while still making progress on project work.
Additional department details are not required at this time.
Additional certifications preferred, for example, but not limited to: Society of Clinical Research Associates (SoCRA), Regulatory Affairs Professionals Society (RAPS), and Association of Clinical Research Professionals (ACRP). A Bachelor's degree in a health care, business, or science related field is required. Master's degree is preferred. Three years of clinical research or monitoring experience preferred. A sound knowledge of Food and Drug Administration's Good Clinical Practices and regulations.
About Sanford Health:
At Sanford Health, we are dedicated to the work of health and healing.
Every day, we show that commitment by delivering the highest quality of care to the communities we serve.
We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.
In addition to strong clinical care, we are also committed to research, education and community growth.
We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases.
We continuously seek new ways to achieve our vision of improving the human condition here in your community,
across the region and around the world.
The entire team at Sanford Health recognizes the value of healthy families and communities.
We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.
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City: Sioux Falls
State: South Dakota
Job Function: Quality & Risk Management
Job Schedule: Full Time
Req Number: req24948