Nancy Campbell Email & Phone Number

Data Innovation Lab

Manage the day to day operations for the Alliance Data Innovation Lab. Continue work on start up initiatives including the Alliance Participant Engagement Portal (PEP) and ICAREdata projects. Work with leaders on strategic planning and infrastructure development for the Data Lab. Contribute to organizational development activities for Alliance Foundation entities.

Boston, Massachusetts, United States

Coordinate and conduct national site engagement, approval, activation and ongoing education on ICAREdata projects and use cases. ICAREdata uses mCODE and innovative ways to structure and extract data for research within the EHR. Project lead for other use cases in the Alliance Data Innovation Lab including the Alliance Participant Engagement Portal (PEP) Working on ongoing global improvements in the conduct of hematology oncology clinical research.

Point of Contact and voting member of the Codex Operating Committee

Coordinated patient care and procedures, per clinical trial protocols, across all disciplines to maintain patient safety and achieve overall protocol compliance as well as ensure data integrity. Planned, implemented and executed clinical trial procedures. Created and developed research documentation, Wrote EPIC treatment plans for investigational drug trials. Worked with budget and contracts, ICF's and performed IRB submissions and other regulatory requirements.Conducted protocol procedures including screening, consenting, documentation, EKG’s, PK blood collections, injectable study medications, assessment of adverse events per CTCAE criteria, evaluation of patients and dose modifications as indicated. Assessed patients for progression of disease using RECIST and iRECIST. Developed and implemented a system-wide communication tool that is still utilized.Participated in site qualification visits, monitoring visits and closeout visits to ensure completeness and accuracy of collected data and site compliance. with CRO vendors and sponsor representatives.Resolved queries within eCRFs and assisted with audits for both pharmaceutical as well as national Cooperative Group hematology/oncology trials and COVID-19 trials.Ensured data quality and compliance by routinely participating in internal monitoring activities and mentoring CRA’s and study team members on protocol directed requirements.Reviewed charges to patient accounts to determine appropriate billing.Adhered to Good Clinical Practice (GCP), HIPAA and ICH Guidelines and FDA Guidance.Educated clinical research coordinators and other associated medical and ancillary staff, on an ongoing basis, in protocol administration, compliance, query resolution as well as internal and external audits processes. Wrote departmental SOP’s. Participated in ongoing continuous quality improvement processes. Compiled project data, performed analysis and prepared reports to present to senior management as needed.

Implemented a new internet based program for tracking consented patients who were at high risk of Colon and Rectal Cancer. Consented and appropriately documented research registry related information. Conducted review of patient care and monitored ongoing compliance with medical recommendations. Wrote reports and submitted annual review for continuation for the registry.

Responsible for regulatory compliance, protocol review, annual review for continuation and policy adherence for all ongoing animal research.Reported to and participated in audits with the United States Department of Agriculture (USDA)Planned and conducted biannual meetings for the IACUC Committee

Conducted protocol related visits in person with subjects which were thoroughly documented. Consented, registered and administered medications as indicated by protocol.Coordinated successful NIH million dollar grant for the BARI 2D study Vanguard Site (nationally acclaimed)

Participated with the development and implementation of this new department.Provided complex urodynamic testing including radiology components to patients.Researched and implemented a successful biofeedback program for patients with urinary incontinence.Served as an industry leader in the field and mentored many healthcare providers from outside institutions on the Center and associated testing.Conducted clinical research on urological devices and investigational medications.Received many awards for poster presentations at national conferences.Invited guest speaker at Annual Convention for Wound Ostomy and Continence Nursing Society.Received national award for highest national score on Urology Certification Exam.Published several articles in national medical journals.Invited community lecturer on urinary incontinence.

Responsible for orientation training and education of all new staff and newly graduated registered nurses.Wrote hospital nursing policies and procedures.Actively participated in Joint Commission on Accreditation of Healthcare Organizations review which resulted in Accreditation with Commendation for the hospital.

Worked in this active leadership position in a management role.Supervised approximately 30 staff nurses, nursing assistants and support personnelMentored and trained new employees.Wrote and administered performance evaluations.

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