Mary Cummings Smolskis
Kensington,USA
Summary
Dedicated operations leader with extensive experience in clinical trial oversight and budget manaDemonstrated ability to develop processes, procedures, and policies that enhance clinical safety and efficiency.iciency. Recognized for empowering teams and driving successful project outcomes through strategic planning and innovative problem-solving.
Overview
40
40
years of professional experience
1
1
Certification
Work History
Section Chief, Operations and Strategy Management Section
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, MD
06.2022 - 05.2025
- Directed clinical operations across multiple projects while supervising teams of up to 100 members.
- Led cross-functional teams in designing new protocols and associated documents for project delivery, and to ensure compliance.
- Established work priorities and managed smooth transition of work between different teams.
- Ensured that quality control measures were implemented consistently.
- Oversaw, developed, and facilitated training sessions to promote best practices among study teams and staff.
- Managed cold and supply chain logistics simultaneously for over ten projects to anticipate demand.
- Participated in statistical analysis plans, and subsequent manuscript development.
- Oversaw approximately $37 million internal annual operating budget.
- Served as the US government Contracting Officer Representative on awarded contracts totaling approximately $375 million.
- Managed stakeholder relationships to align goals and expectations across the organization.
- Used strong issue resolution and communication skills to cultivate and strengthen lasting client relationships.
- Evaluated program effectiveness and recommended improvements for processes.
- Collaborated with the finance team to manage domestic and international operating budgets.
- Participated in the technical writing and review of contract statements of work and task orders.
- Managed strategic planning internally and with government-to-government partnerships.
- Collaborated on crucial strategic decision-making alongside partners, including public health ministries.
- Facilitated collaboration with US Embassies to oversee relationships, health, and clinical research activities.
- Ensured transparency and consistency representing operations on executive committees.
- Cultivated daily interactions with staff and teams promoting synergy and cooperation.
- Mentored team members to improve skills, foster professional development, and build capacity.
- Organized international meetings with the goal of disseminating data and best practices.
- Gained the trust of leadership and staff to manage personnel issues, expectations, and timelines.
- Conducted performance reviews with direct reports to assess individual performance levels, identify areas of improvement and provide coaching as needed.
- Provided strategic direction to staff on priority projects, assigned tasks to team members, monitored progress and ensured deadlines were met.
- Developed, implemented, and maintained project management priority tracking tools.
- Reviewed with teams the efficiency and relevance of existing and new IT operations tools.
- Developed relevant operating procedures and metrics as part of the accountability process.
- Organized meetings to address complex regulatory and compliance issues.
- Provided recommendations to contractors regarding relevant staff performance indicators.
- Consulted with stakeholders to determine culturally appropriate communication techniques.
- Resolved conflicts among team members by facilitating open dialogue between parties involved.
- Regularly reviewed operational performance metrics and accountability, and provided feedback to ensure goals were achieved within established timelines.
Clinical Research Oversight Manager
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
01.2007 - 06.2022
- Project lead of over 10 sites in executing clinical trials for influenza, Zika, and COVID-19 in Mexico.
- Managed multiple domestic and international clinical protocols while serving as clinical operations co-lead.
- Assisted in executing ACTT (COVID-19) vaccine trial processes while stationed in Seoul, South Korea.
- Chosen for initial team to evaluate and train on Ebola response trials in Liberia, Guinea, and DRC
- Coordinated site opening activities for several emergency response sites/studies.
- Sustained and enhanced institutional Risk Management Assessment tool.
- Acquired Contract Officer Representative certification, augmenting decision-making capabilities.
- Designed innovative, user-friendly study flow diagrams, study brochures, and study tools.
- Streamlined and optimized all training resources and sessions across various projects/studies
- Assessed in-country capacity and needs to determine the best model for training.
- Coached in-country staff to foster autonomy in curriculum design and training delivery.
- Provided CEU training in 2021, 2020, and 2019 - Training on a Global Scale: Sponsored by the University of Texas Medical Branch and the Food and Drug Administration.
- Trained employees on additional job positions to maintain coverage of roles.
- Delegated work to staff, setting priorities and goals.
- Conducted regular meetings with staff to discuss progress and identify areas of improvement.
- Assessed team member's skillsets and assigned tasks accordingly for optimal efficiency.
- Established processes to ensure efficient workflow throughout the organization.
- Managed vendor relationships by negotiating contracts and ensuring timely delivery of goods and services.
- Monitored budgets and expenditures to ensure cost-effectiveness while maintaining quality standards.
- Negotiated contracts and agreements with vendors and suppliers to reduce costs.
- Reviewed completed work to verify consistency, quality, and conformance.
- Implemented new procedures to improve operational efficiency within the institute.
- Developed strategic partnerships with external organizations to foster collaborative research efforts.
- Ensured compliance with all applicable laws, regulations, industry standards.
Clinical Project Manager
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
01.2002 - 10.2009
Project Nurse
CODA Incorporated
Silver Spring, USA
10.2001 - 01.2002
Nurse Consultant
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
04.2000 - 09.2001
Research Study Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
01.1999 - 04.2000
Nurse Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
01.1998 - 01.1999
Nurse Consultant
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
02.1994 - 01.1998
Clinical Research Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
09.1992 - 02.1994
Senior Clinical Nurse
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, USA
03.1988 - 09.1992
Ambulatory Staff Nurse
The Washington Clinic
Washington, USA
08.1987 - 03.1988
Clinical Nurse
National Cancer Institute
Bethesda, USA
08.1985 - 08.1987
Education
Masters of Case Management - Health Promotion Counseling
Trinity College
Washington, DC05.1995
Bachelor of Science - Nursing
Georgetown University School of Nursing
Washington, DC05.1985
Skills
- Team leadership
- Clinical operations management
- Regulatory compliance
- Document development
- Budget oversight
- Strategic planning
Degrees
- BSN
- MA
Telephone
cell, 301-767-5282
Awards
- 2022, 2017-Health and Human Services Secretary's Award
- 2021, 2020, 2018, 2014-NIH Director's Award
- 2017, 2016-NIH Clinical Center Director's Award
- 2015-1987- Multiple NIAID group, merit, incentive performance awards
Publications
18 Peer-Reviewed Journal Articles; Acknowledged in 11 Peer-Reviewed Journal Articles
- Immunogenicity of COVID-19 Booster Vaccines in Mexico and Mongolia, Open Forum Infectious Diseases, 2025, Supplement I.
- Community Engagement and Local Collaboration: A Collaboration Framework to Enhance Women's Participation in a COVID-19 Vaccine Immunogenicity Study in Liberia, Research Square Pre-Print, 2024.
- International Clinical Research Networks - A Collaborative Approach for Pandemic Preparedness and Response: The Case of the Mexican Emerging Infectious Disease Clinical Research Network (LaRed), Journal of Global Health, 2023, APR.
- Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE), PLoS ONE, 2022.
- Community-based hospitals: New partners of government-sponsored clinical research during public health emergencies, 2021, Vaccine, 39, 42, 6183-6185.
- A Unique Immune Signature of Serum Cytokine and Chemokine Dynamics in Patients in Zika Virus Infection from a Tropical Region in Southern Mexico, International Journal of Infectious Diseases, 2020, 94, 4-11.
- Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness, Clinical Infectious Diseases, 2019, 1-9.
- Differential Risk of Hospitalization Among Single Virus Infections Causing Influenza-like Illnesses, Influenza and Other Respiratory Viruses, 2019, 13, 1, 136-143.
- Reliability, Validity, and Responsiveness of Influenza Patient-Reported Outcome (FLU-PRO) Scores in Influenza-Positive Patients, Value in Health, 2018, 210-218.
- A Randomized Trial Comparing Concise and Standard Consent Forms in the START Trial, PLoS ONE, 2017, 1-11, An Observational Study to Determine the Causes and Identity Increases in Influenza-Like Illness (ILI) in Mexico, Open Forum Infectious Diseases, 2016, 3, 1, 1-5.
- Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak, Contemporary Clinical Trials Communications, 2016, 4, 4-19.
- Reported consent processes and demographics: A Sub-study of the INSIGHT Strategic Timing of Antiretroviral Treatment (START) trial, HIV Medicine, 2015, 16, 24-9.
- OECD Recommendation on the Governance of Clinical Trials, OECD, 2013, 1-45, Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases, Clinical Trials, 2009, 6, 386-391.
- Immune Globulin Prophylaxis of Respiratory Syncytial Virus Infection in Patients Undergoing Stem-Cell Transplantation, Journal of Infectious Diseases, 2000, 186, 834-838.
- Pooled Analysis of 3 Randomized, Controlled Trials of Interleukin-II Therapy in Adult Human Immunodeficiency Virus Type I Disease, Journal of Infectious Diseases, 2000, 182, 428-434.
- Comparative Safety, Tolerance, and Pharmacokinetics of Amphotericin B Lipid Complex and Amphotericin C Desoxycholate in Healthy Male Volunteers, Journal of Infectious Diseases, 1991, 164, 418-42.
Acknowledgments
- Guillain-Barre Syndrome Outbreak in Tapachula temporally associated with Zika Virus introduction in Southern Mexico, Epidemiology and Infection, 2022
- Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico, Open Forum Infectious Diseases, 2022
- Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial, The Lancet, 2022, 399, 10324, 530-540
- Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-blind, randomised, placebo-controlled, phase 3 trial, The Lancet, 2021, 9, 12, 1365-1376
- Remdesivir for the Treatment of COVID-19 - A Preliminary Report, The New England Journal of Medicine, 2020, 1-12
- Comparison of Rates of Hospitalization Between Single and Dual Virus Detection in a Mexican Cohort of Children and Adults with Influenza-Like Illness, Open Forum Infectious Diseases, 2019, 1-8
- A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics, The New England Journal of Medicine, 2019, 381, 2293-303
- Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia, The New England Journal of Medicine, 2017, 377, 1438-1447
- Cerebrospinal Fluid Examination in Survivors of Ebola Virus Disease, JAMA Neurology, 2017, 74, 9, 1141-1143
- A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection, The New England Journal of Medicine, 2016, 1448-1456
- Use of Recombinant Soluble CD4 Pseudomonas Exotoxin for Treatment of Persons Infected with Human Immunodeficiency Virus, Journal of Infectious Diseases, 1994
Textbook Contribution
Principles and Practices of Emergency Response Research, https://link.springer.com/book/10.1007/978-3-031-48408-7?page=4#toc, Selecting and Opening a Clinical Research Site in a Low-Resource Setting, Locally Hired Staff for Clinical Research Sites in Low-resource Settings
Affiliations
- Marathon and other running events participation
- Gardening
- Reading
- Biking
Accomplishments
- 2022 and 2017 - HHS Secretary's Award
- 2021, 2020, 2018, 2014 - NIH Director's Award
- 2017, 2016 - NIH Clinical Center Director's Award
- 2015-1987 - Multiple NIAID group, merit, incentive performance awards
- TEXTBOOK CONTRIBUTION
Principles and Practices of Emergency Response Research: https://link.springer.com/book/10.1007/978-3-031-48408-7?page=4#toc
Selecting and Opening a Clinical Research Site in a Low-Resource Setting
Locally Hired Staff for Clinical Research Sites in Low-resource Settings
PUBLICATIONS
Immunogenicity of COVID-19 Booster Vaccines in Mexico and Mongolia, Open Forum Infectious Diseases 2025; Issue Supplement I.
Community Engagement and Local Collaboration: A Collaboration Framework to Enhance Women’s Participation in a COVID-19 Vaccine Immunogenicity Study in Liberia, Research Square Pre-Print 2024.
International Clinical Research Networks - A Collaborative Approach for Pandemic Preparedness and Response: The Case of the Mexican Emerging Infectious Disease Clinical Research Network (LaRed), Journal of Global Health: APR 2023.
Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE), PLoS ONE; 2022.
Community-based hospitals: New partners of government-sponsored clinical research during public health emergencies, 2021, Vaccine Volume 39, Issue 42:6183-6185.
A Unique Immune Signature of Serum Cytokine and Chemokine Dynamics in Patients in Zika Virus Infection from a Tropical Region in Southern Mexico, International Journal of Infectious Diseases 2020; 94: 4-11.
Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness, Clinical Infectious Diseases 2019; 1-9.
Differential Risk of Hospitalization Among Single Virus Infections Causing Influenza-like Illnesses, Influenza and Other Respiratory Viruses 2019; 13: 1: 136-143.
Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO) Scores in Influenza-Positive Patients, Value in Health, 2018; 210-218.
A Randomized Trial Comparing Concise and Standard Consent Forms in the START Trial, PLoS ONE 2017; 1-11.
An Observational Study to Determine the Causes and Identity Increases in Influenza-Like Illness (ILI) in Mexico, Open Forum Infectious Diseases 2016; 3: 1-5.
Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak, Contemporary Clinical Trials Communications 2016; 4: 4-19.
Reported consent processes and demographics: A Sub-study of the INSIGHT Strategic Timing of Antiretroviral Treatment (START) trial, HIV Medicine 2015; 16: 24-9.
OECD Recommendation on the Governance of Clinical Trials, OECD 2013; 1-45.
Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases, Clinical Trials 2009; 6: 386-391.
ImmuneGlobulin Prophylaxis of Respiratory Synctial Virus Infection in Patients Undergoing Stem-Cell Transplantation, Journal of Infectious Diseases 2000; 186: 834-838..
Pooled Analysis of 3 Randomized, Controlled Trials of Interleukin-II Therapy in Adult Human Immunodeficiency Virus Type I Disease, Journal of Infectious Diseases 2000; 182: 428-434.
Comparative Safety, Tolerance, and Pharmacokinetics of Amphotericin B Lipid Complex and Amphotericin C Desoxycholate in Healthy Male Volunteers, Journal of Infectious Diseases 1991; 164: 418-42.
ACKNOWLEDGMENTS
Guillain-Barre Syndrome Outbreak in Tapachula temporally associated with Zika Virus introduction in Southern Mexico, Epidemiology and Infection; 2022.
Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico, Open Forum Infectious Diseases 2022.
Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial, The Lancet 2022; Volume 399, Issue 10324, 530-540.
Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-blind, randomised, placebo-controlled, phase 3 trial, 2021 The Lancet Volume 9, Issue 12, 1365-1376.
Remdesivir for the Treatment of COVID-19 – A Preliminary Report, The New England Journal of Medicine 2020; 1-12.
Comparison of Rates of Hospitalization Between Single and Dual Virus Detection in a Mexican Cohort of Children and Adults with Influenza-Like Illness, Open Forum Infectious Diseases 2019; 1-8.
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics, The New England Journal of Medicine 2019; 381:2293-303.
Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia, The New England Journal of Medicine 2017; 377: 1438-1447.
Cerebrospinal Fluid Examination in Survivors of Ebola Virus Disease, JAMA Neurology 2017; 74(9): 1141-1143.
A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection, The New England Journal of Medicine 2016; 1448-1456.
Use of Recombinant Soluble CD4 Pseudomonas Exotoxin for Treatment of Persons Infected with Human Immunodeficiency Virus, Journal of Infectious Diseases 1994.
Certification
- Good Clinical Practice Certification
- Human Subjects Protection Certification
- Contract Officer Representative - Level III
- Chemotherapy Certification
- District of Columbia Nursing License - expired 2020
References
References available upon request.
Timeline
Section Chief, Operations and Strategy Management Section
National Institute of Allergy and Infectious Diseases (NIAID)
06.2022 - 05.2025
Clinical Research Oversight Manager
National Institute of Allergy and Infectious Diseases (NIAID)
01.2007 - 06.2022
Clinical Project Manager
National Institute of Allergy and Infectious Diseases (NIAID)
01.2002 - 10.2009
Project Nurse
CODA Incorporated
10.2001 - 01.2002
Nurse Consultant
National Institute of Allergy and Infectious Diseases (NIAID)
04.2000 - 09.2001
Research Study Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
01.1999 - 04.2000
Nurse Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
01.1998 - 01.1999
Nurse Consultant
National Institute of Allergy and Infectious Diseases (NIAID)
02.1994 - 01.1998
Clinical Research Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
09.1992 - 02.1994
Senior Clinical Nurse
National Institute of Allergy and Infectious Diseases (NIAID)
03.1988 - 09.1992
Ambulatory Staff Nurse
The Washington Clinic
08.1987 - 03.1988
Clinical Nurse
National Cancer Institute
08.1985 - 08.1987
Masters of Case Management - Health Promotion Counseling
Trinity College
Bachelor of Science - Nursing
Georgetown University School of Nursing
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