Sally Scherer-Pinsley has over 15 years of experience in clinical research and quality assurance. She is currently the Interim Administrative Director of the Robert H. Lurie Comprehensive Cancer Center Research Oversight System at Northwestern University, where she oversees various committees and ensures appropriate management of meetings. Previously, she held roles as Quality Control Manager and Quality Assurance Department Manager at the Lurie Cancer Center, where she implemented quality assurance programs, conducted audits, and managed over 100 affiliate sites. She has a Bachelor's degree in Anthropology and Sociology from the University of Notre Dame and is a certified clinical research associate.
Developing an effective local quality improvement programmeCarl Walker
I gave this presentation at Clinical Audit for Improvement conference in October 2016 on behalf of National Quality Improvement & Clinical Audit Network (@nqican)
Developing an effective local quality improvement programmeCarl Walker
I gave this presentation at Clinical Audit for Improvement conference in October 2016 on behalf of National Quality Improvement & Clinical Audit Network (@nqican)
Dr. Paul Sundberg - Preparing for potential and emerging swine diseases: Swin...John Blue
Preparing for potential and emerging swine diseases: Swine Health Information Center Update - Dr. Paul Sundberg, Executive Director, Swine Health Information Center, from the 2016 Minnesota Pork Congress, January 18 - 20, 2016, Minneapolis, MN, USA.
More presentations at http://www.swinecast.com/2016-minnesota-pork-congress
N-QI-CAN brings together the regional clinical audit / effectiveness networks from across England. There are 14 regional clinical audit/effectiveness networks all of whom have representatives regularly attending NQICAN meetings. Wales and Northern Ireland are also represented on the group to enable sharing of good practice and collaborative working.
NQICAN has several 'stakeholder members' including NHS England, HQIP and NICE. Several of the Royal Colleges and other key stakeholders are represented.
This is the NQICAN annual report for 2016.
Alex Shirreffs, the HIV/HCV Project Coordinator at the Philadelphia Department of Public Health, presented on Hepatitis C and HIV co-infection at the April 2017 meeting of the Positive Committee.
Dr. Paul Sundberg - Preparing for potential and emerging swine diseases: Swin...John Blue
Preparing for potential and emerging swine diseases: Swine Health Information Center Update - Dr. Paul Sundberg, Executive Director, Swine Health Information Center, from the 2016 Minnesota Pork Congress, January 18 - 20, 2016, Minneapolis, MN, USA.
More presentations at http://www.swinecast.com/2016-minnesota-pork-congress
N-QI-CAN brings together the regional clinical audit / effectiveness networks from across England. There are 14 regional clinical audit/effectiveness networks all of whom have representatives regularly attending NQICAN meetings. Wales and Northern Ireland are also represented on the group to enable sharing of good practice and collaborative working.
NQICAN has several 'stakeholder members' including NHS England, HQIP and NICE. Several of the Royal Colleges and other key stakeholders are represented.
This is the NQICAN annual report for 2016.
Alex Shirreffs, the HIV/HCV Project Coordinator at the Philadelphia Department of Public Health, presented on Hepatitis C and HIV co-infection at the April 2017 meeting of the Positive Committee.
Experienced Clinical Research Associate with over 5 years of experience in the clinical research in Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Experience working on phases I, II and III clinical trials.
1. Sally Scherer-Pinsley
5313 N. Ravenswood, #102
Chicago, IL 60640
773-343-4934
sallyschererpinsley@gmail.com
EDUCATION
The University of Notre Dame, 1996-2000
Bachelor of Arts, Anthropology and Sociology
PROFESSIONAL CERTIFICATIONS & ASSOCIATIONS
ACRP Clinical Research Associate Certification, March 2015
Member of Association of Clinical Research Professionals (ACRP), January 2015-present
RESEARCH EXPERIENCE
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Interim Administrative Director, Robert H. Lurie Comprehensive Cancer Center, Research Oversight
System
September 2016-present
• Oversee and provide guidance for the activities of the committees that comprise the Lurie Cancer
Center Research Oversight System, including the Disease Teams, the Scientific Review Committee
(SRC), the Data Monitoring Committee (DMC) and the Clinical Trial Audit Committee (CTAC),
including:
• Ensure appropriate management of meetings, making sure their scope and function is consistent
with NCI guidelines.
• Manage all staff who support these committees, the appropriate support for the activities of the
committees, ensuring written material and reports for each meeting are completed and
distributed appropriately.
• Oversee the activities of the quality assurance program, ensuring activities of the program meet
best practices and federal requirements for compliance.
• Develop and maintain SOPs and policies relevant to research oversight and compliance. Develops
metrics and reviews committee performance and workflow, ensuring that expectations are met
and modifying process as necessary.
Quality Control Manager and Quality Assurance Department Manager
January 2013-present
• Implemented and manages quality assurance program for a profile of 70 Lurie Cancer Center
investigator-initiated cancer-relevant trials (IITs)
• Responsible for direct supervision and management of all CRO QA and/or QC staff members,
including hiring, training, oversight, performance review and training of such staff.
• Evaluates and makes recommendations regarding all Cancer Center new IITs for feasibility,
scientific merit, and adherence to Lurie Cancer Quality Assurance requirements.
2. • Collaborates with bioinformatics team to develop and implement customized eCRFs for all
investigator-initiated trials.
• Routinely conducts routine and for-cause audits for all types of Lurie Cancer Center trials.
• Manages a network of over 100 affiliates participating in Northwestern investigator-initiated
trials.
Quality Control Manager
January 2009-January 2013
• Established a comprehensive quality control program for the CRO, including:
o Development and implementation of approximately 70 formalized Standard Operating
Procedures (SOPs) across every aspect of Lurie Cancer Center’s research activities.
o Development of comprehensive training program for all new employees.
o With cancer center leadership, ensured that all SOPs were reviewed, updated and
training was provided as required.
• Developed internal CRO audit program to ensure compliance with federal and institional
requirements and SOPs, and to ensure quality standards are maintained.
• Re-launched and maintained the Lurie Cancer Center’s Clinical Research Office website.
• Served as the Quality Improvement Representative for National Comprehensive Cancer Network’s
Opportunity for Improvement Project.
Takeda Global Research & Development Center, Inc., contracted through Delta Pharma
March 2008-January 2009
Senior Clinical Trial Associate
• Worked closely with the Study Manager and Project/Study Team in organizing and executing pre-
study activities.
• Conducted site evaluation visits, routine monitoring visits, and assisted sites with audit
preparation.
• Coordinated the initial and ongoing submissions of required documentation to central and local
IRBs.
• Critically reviewed regulatory documents for quality and completeness in accordance with
appropriate regulations and the study protocol. Ensure all required documents are archived
appropriately.
• Monitored status of CDA/site contract negotiations and finalization as it occurs through the
Outsourcing department.
• Communicate with clinical sites regarding document issues/discrepancies.
• Work with Clinical Operations and Site Operations staff to ensure complete and accurate
accounting of investigational product shipments, clinical site receipts, and returns for destruction;
work with the Study Manager and monitoring staff to complete ongoing and final reconciliation of
investigational product.
• Input and keep current all investigator and study-specific information in the clinical trial
management system. Perform quality checks of information contained in the clinical trial
management system to ensure accuracy in investigator contact information and document receipt
status.
3. The University of Chicago, Cancer and Leukemia Group B
February 2005-March 2008
Audit Coordinator
• Coordinated all auditing activities for the Cancer and Leukemia Group B (CALGB), a national
oncology research group with 225 institutional members to ensure regulatory and data
compliance. Coordinated a group of 140 volunteer physicians and scheduled over 100 audits a
year.
• Conducted both off-site and on-site audits of institutional members.
• Served as the CALGB Central Office contact regarding audit questions from the CTMB, CTSU, and
CALGB group members and negotiated controversial issues between all groups.
• Reviewed, edited, approved audit reports and submitted audit information to the National Cancer
Institute (NCI).
• Conducted quarterly sessions to train group Clinical Research Associates and Principal
Investigators to prepare for and conduct CALGB audits.
• Coordinated distribution of audit reports to institutional members, evaluated institutional
responses, and submitted responses to the CTMB; provided targeted suggestions and resources
for corrective action plans to assist institutions in improving performance.
• Evaluated and analyzed audit trends and worked with the Data Audit Committee (DAC) and
CALGB staff to develop appropriate training for CALGB institutions and volunteer auditors. Then,
developed education and training materials related to audit and regulatory compliance in
conjunction with the DAC. Routinely presented curriculum to members in a series of workshops.
PUBLICATIONS
Nora Hansen, MD; Sally Anne Scherer; and Seema Khan, MD (2014). Quality Improvement Project:
Opportunities for Improvement. Journal of the National Comprehensive Cancer Network 2014 Jan; Volume 12,
Supplement 1.
OTHER WORK EXPERIENCE
Heartland Alliance, Families Building Communities February 2004-
August 2004
Senior Case Manager
• Managed over 20 families and 80 individual cases.
• Built relationships with 150 Illinois agencies that served as resources for clients.
• Provided a variety of services to participants, including referral services, life skills counseling,
budgeting and advocacy.
Deborah’s Place, Teresa Transitional Shelter November 2001-
February 2004
Assistant Manager
• Responsible for the daily programming and operations of Teresa’s Transitional Shelter.
Supervised volunteer and program staff and ensured program safety and integrity.
4. • Wrote four proposals to Illinois Department of Human Services to increase funding, reorganize
program, and assure program compliance. All were successful.
• Created brochures for fundraising and to solicit referral business.
• Wrote regular reports for management, including case analysis and monthly summaries.
• Monitored program space and program participants; assisted participants with daily living; adept
at conflict resolution, crisis intervention, and advocacy. Skilled at handling weekly crisis situations
for women in shelter.
• Worked with Program Administrator to maintain program goals and yearly projection of service.
Franciscan Outreach Association November 2000-February
2001
Women’s Dorm Manager
• Supervised and monitored 35 women experiencing homelessness in an emergency overnight
shelter while living on-site as a full-time Americorps volunteer. Planned and oversaw operations
of the women’s dormitory, supervised other volunteers, and created women’s dorm work
schedule.
• Developed first-ever employee recruitment program for entire agency and organized recruitment
trips to Midwestern universities to fill slots for Americorps volunteers.