Mary Kelly
Houston,USA
Summary
Experienced Research Nurse with 20+ years background in clinical trials and patient-centered research. Key strengths include data analysis, direct patient care, and regulatory compliance for healthcare research protocols. Demonstrated ability to ensure accurate data collection, contribute to research integrity, and advocate for patient rights. Have made significant contributions to multiple successful research projects.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Research Nurse Supervisor
MD Anderson Cancer Center
Houston, Texas
01.2016 - 01.2024
- Company Overview: Therapeutic Areas: Phase I, II, III, IV trials for AML, MDS, ALL, T-Cell ALL, CLL, Myelodysplastic Syndrome,CAR-T, Immunotherapies, Immune Modulators, Chemotherapy, BiTE,Cellular products
- Supported Key Opinion Leaders in Leukemia Research
- Managed enrollment in over 200 complex leukemia protocols, team frequently assumed lead position for multi-center trials
- Site lead in keystone trials including VIALE-2 trial.
- Expertly developed team of 8-10 Clinical Study Managers enrolling an average of 40 patients per month.
- Trained hospital staff on protocol requirements and ensured adherence to ICH-GCP standards
- Authored amendments, Single Patient IND protocols, Compassionate care protocols
- Collaborated with Sponsors, CRO vendors to improve enrollment, monitoring
- Co-authored multiple science papers presented at ASH, ASCO and in leading scientific journals
- Spearheaded collaborations committee with Leukemia Nurse Leadership, reducing deviations by 30% and enhancing communication across the patient care matrix
- Improved resource management, cohesion of data entry and engagement with research team
- Implemented change in nurse orientation to include, nursing management of patients enrolled in research.
Research Nurse Specialist
MD Anderson Cancer Center
Houston, TX
01.2010 - 01.2016
- Company Overview: Therapeutic Areas: Phase I, II, III, IV trials for AML, MDS, B-Cell ALL, T-Cell ALL, CLL, Myelodysplastic Syndrome
- Immunotherapies, Immune Modulators, CXCR-4 Inhibitors, Chemotherapy, BiTE, Novel Cellular products
- Managed complex patient coordination for 30+ leukemia research protocols, ensuring protocol adherence and regulatory compliance
- Monitored patient safety during clinical trials and reported adverse events to the necessary regulatory bodies including FDA, IRB, WIRB, Industry Sponsors and CROs
- Functioned as liaison between matrix for internal and external stakeholders to ensure patient-centered care and protocol compliance
- Consented and recruited clinical research subjects, monitored enrollment goals and adjusted recruitment strategies, which led to Site Lead position for multi-centered trials
- Entered and monitored data entry, collaborating with sponsors and CROs
- Mentored new nurses through complexities of clinical research.
- Functioned as key resource for team of research nurses within hematology research department.
- Collaborated with Key Opinion Leader and molecular research team to promote novel therapeutics presented at ASH, ASCO and in leading scientific journals
- Contributed to developing study reports and presentations, translating complex clinical data into actionable insights for stakeholders, including commercial teams
- Successfully engaged in peer-to-peer reviews with insurance providers to cover patient costs for novel therapeutic products.
Clinical Program Coordinator/Research Nurse Coordinator
Cedars-Sinai Medical Center
Los Angeles, CA
01.2005 - 01.2010
- Company Overview: Therapeutic Areas: Phase I, II, III, IV trials for AML, T-Cell ALL, B-Cell ALL, Myelodysplastic Syndrome, Germ Cell Lymphoma, DLBC Lymphoma, Mantle Cell Lymphoma, Multiple Myeloma
- Coordinated care and education for patients requiring stem cell transplants, including autologous, allogeneic MUD, and MRD
- This included product, donor selection through NMDP
- Managed > 200 patient case load leading to 50% of 82 million dollar profit in single fiscal year
- Authored trial protocols for bloodless stem cell transplants for Jehovah Witness patients; improving patient safety and trial adherence
- Liaised across stakeholder matrix to improve patient care coordination, recruitment, insurance approval and long term follow up
- Contributed to development of harmonized database, achieved 2 years ahead of ICH mandate for database harmonization
- Engaged in peer-to-peer review for authorization of treatments with Director of Medi-Cal, Insurance companies, Medicare
- Participated in contract renegotiations with aforementioned entities resulting in increased contracted rates for transplants and new referral base
- Participated in successful FACT, Magnet accreditation
- Successfully advocated change of protocol for Germ Cell Lymphoma induction, consolidation and transplant therapy utilizing comparative data reporting to support change leading to improved outcomes
- Represented team in Shared Governance Committee with inpatient nursing
- Increased collaboration, improved communication, patient safety resulting in Magnet Recognition Award for innovation
Skills
- Clinical research management
- Patient and family education
- Multidisciplinary team collaboration
- Protocol development
- ICH-GCP compliance
- Clinical data entry and reporting
- Bone Marrow and Cellular transplant
- Budget and fiscal management
- Protocol submission to IRB, IND, FDA
- Problem resolution
- Analytical skills
- Peer to Peer review
- Leadership and mentorship
- FDA and sponsor audit experience
- Verbal and written communication skills
- Critical thinking skills
- Time management
- Pre-site selection
- SIV
- Close out visit
- CAR-T and novel cellular therapies
- Clinical trial protocols
Certification
- Research Audit Certification (MD Anderson Cancer Center)
- C.I.T.I Certification (MD Anderson Cancer Center)
- GCP/ICH Certification (updated 2023)
- IRB Certification (MD Anderson Cancer Center)
- OnCORE Certification (MD Anderson Cancer Center)
- Medidata’s Rave EDC Certification (MD Anderson Cancer Center)
- Chemotherapy Nurse Certification (UAMS)
- High Dose Interleukin-2 Certification (UCLA)
- BCLS (expires 06/2025)
Education And Licensing
- The Waltham Forest School of Nursing, Credentialed Registered General Nurse, United Kingdom
- Texas Board of Nursing, 783139, 05/31/25
Timeline
Research Nurse Supervisor
MD Anderson Cancer Center
01.2016 - 01.2024
Research Nurse Specialist
MD Anderson Cancer Center
01.2010 - 01.2016
Clinical Program Coordinator/Research Nurse Coordinator
Cedars-Sinai Medical Center
01.2005 - 01.2010
- Research Audit Certification (MD Anderson Cancer Center)
- C.I.T.I Certification (MD Anderson Cancer Center)
- GCP/ICH Certification (updated 2023)
- IRB Certification (MD Anderson Cancer Center)
- OnCORE Certification (MD Anderson Cancer Center)
- Medidata’s Rave EDC Certification (MD Anderson Cancer Center)
- Chemotherapy Nurse Certification (UAMS)
- High Dose Interleukin-2 Certification (UCLA)
- BCLS (expires 06/2025)