Clinical Trials Office Directory

  • Yolanda Ruiz is a Financial Analyst at the Clinical Trials Office. Yolanda provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center.

  • Manager, IRB 3

  • Wendy Lora is a Pharmacy Technician. She signs out and delivers study medication and conducts site qualification visits and interim monitoring visits in addition to managing drug inventory and pharmacy supplies ordering.

  • Victoria Hamilton created and directs the Office of Research Initiatives at Columbia University, reporting to the Executive Vice President for Research. This Office works across disciplines, schools, and campuses to foster interdisciplinary research collaboration, particularly among scientists, engineers, and medical researchers. The Office supports efforts to secure external funding for such collaborations, and administers a seed fund for very early-stage research that falls outside the traditional boundaries. The Office also focuses on helping plan and build research infrastructure, such as the Shared Research Computing Facility and the Columbia Nano Initiative facilities.

    Prior to joining Columbia in January 2007, Ms. Hamilton was a principal of The Washington Advisory Group, consulting with both industry and non-profits on the intersection of scientific and technical research and commerce (1999 to 2006). Previously, she was Chief Operating Officer and Executive Vice President of General American Investors, a NYSE-listed closed end investment fund (1992-1998), and for ten years a senior member in SRK Management Company, a private venture capital firm (1982-1992). Ms. Hamilton holds a BA and an MBA from Harvard University.

  • Role and Responsibilities

    Susan is the Finance Manager for the Executive Vice President of Research overseeing all Central Finances and Reporting relating to the 9 EVPR units.

    Biography

    As a 10 year veteran of Columbia University, Susan served as Contract control specialist in the Department of Sponsored Projects Administration (formerly known as OPG) where she was responsible for the Data entry of awarded information into the grants management system for account creation and account Modifications. She was also responsible for post data entry, review and reconciliation of the information and attributes fed from the grants management system to the University financial system to ensure both systems were synchronized.  Susan also served as the Financial Assistant in the Department of Dermatology, as well as the Financial Coordinator for Columbia’s Biomedical Informatics Department.  In both capacities, she was responsible for review of financial activities such as reconciling grant and departmental accounts against the university financial systems, liaison between the IRB, IACUC and SPA for departmental requests and completion of such requests. In addition to but not limited to maintenance/execution of subcontract and consulting agreements and assist with the submission of grant proposals.  

    Mrs. Richards earned a Bachelor of Science degree in Finance and Business Management from Delaware State University in Dover, DE.  A native of Brooklyn, NY, Susan likes to learn new concepts to excel at her position at Columbia University, read, and spend time with family.

  • Stephanie is responsible for educating and updating the Columbia University community on policies and procedures impacting the day to day management of proposals and awards. She has over twenty years' experience in all aspects of pre-award sponsored projects administration, and has led many special projects involving the implementation and change management of major policies and systems. Stephanie has conducted many training initiatives on complex topics such as the Uniform Guidance, federal public access policies, and the Fly America Act. She is currently the Co-Chair of the Federal Demonstration Partnership (FDP) Subawards Subcommittee, and a member of NCURA's Professional Development Committee (PDC) responsible for the development of their online programming.  She holds a Master's Degree in Epidemiology and is a Certified Research Administrator (CRA).

  • Stacy Lynn Siegel, JD, is a Senior Contract Specialist with the Clinical Trials Office. She negotiates and finalizes an array of research related agreements on behalf of the research community at P&S. Stacy also advises faculty and staff on applicable laws and institutional policies governing human subjects research.

  • Sharmin Hossain, MS, is a Financial Analyst at the Clinical Trials Office. Sharmin provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center.

  • Seretha Houston is a Senior Accountant at the Clinical Trials Office. Seretha provides allocation services for industry-sponsored clinical trial projects, which includes lockbox reconciliation and closeout transfers at Columbia University Medical Center.

  • Ruth Gutierrez is the Research Applications Analyst at the Clinical Trials Office. Ruth provides application support to the Columbia University Medical Center community. She is also involved in the application configuration, data management, and quality assurance of CTO applications, including StudyManager.

  • Dr. Odeh-Ramadan is the Vice President for Research Administration at Columbia University. She oversees the Sponsored Projects Administration Office, Research Pharmacy and the Clinical Trials Office.

  • Rose Lulgiuraj is a Budget Analyst with the Clinical Trials Office. She is responsible for determining financial feasibility and negotiating directly with pharmaceutical companies to ensure compliance with University policies and procedures.

  • Rahel James is a Senior Budget Analyst with the Clinical Trials Office. She is responsible for determining financial feasibility and negotiating directly with pharmaceutical companies to ensure compliance with University policies and procedures.

  • Nenjae Gibson, JD, is a Senior Contract Specialist with the Clinical Trials Office. She negotiates and finalizes an array of research related agreements on behalf of the research community at P&S. Nenjae also advises faculty and staff on applicable laws and institutional policies governing human subjects research.

  • Naomi Schrag is the Vice President for Research Compliance, Training, and Policy in the Office of the Executive Vice President for Research, and the University's Research Integrity Officer (RIO). She oversees work on issues such as research misconduct, conflict-of-interest and international research compliance, and collaborates closely with other offices across the University to develop integrated approaches to compliance and training.

  • Roles and Responsibilities

    Michelle Benson is the Assistant Director for Research Integrity and Compliance. Her work focuses on promoting research and data integrity through various workshops and trainings, research group consultations and development of resources to aid in the conduct of research. She also works on matters concerning conflict-of-interest and research misconduct.

    Biography

    Dr. Benson has a Ph.D. in Materials Chemistry from the University of Wisconsin-Madison. Her dissertation focused on heterogenous catalysis by developing new surface functionalization techniques on nanoscale metal oxides. In addition to her research at UW-Madison, Dr. Benson also worked with the Wisconsin Alumni Research Foundation on projects involving outreach, technology transfer, and research collaboration. Before coming to Columbia in January 2014, Dr. Benson was an adjunct professor teaching undergraduate chemistry to science majors and nursing students.

  • Roles and Responsibilities

    Michelle Avallone is the Director of Export Controls. Her work focuses on matters relating to export controls and international research.

    Biography

    Before joining Columbia in 2013, Ms. Avallone was an attorney in private practice focusing on government contracts and export controls. Ms. Avallone graduated from Columbia Law School in 2006. Prior to law school, she received a M.A. in Anthropology from Columbia University. 

  • Michael Shelter is an Executive Assistant within the Office of the Executive Vice President for Research. In this role, he will be responsible for the calendar management for Victoria Hamilton and Adrian Hill, internal communications, meeting and event planning, and special projects including various functions in the 409A Low Library Office.

    Prior to joining Columbia, Michael worked as a Car Free Day Coordinator and Participatory Budgeting Coordinator for NYC Council Member Ydanis Rodriguez. Additionally, he served as Council Member Rodriguez’s Education & Environmental Policy Intern, and as Communications Intern for the New York League of Conservation Voters. During his time as a student at The New School, he was part of a team of Research Assistants that helped in promoting the culture and awareness around sustainability while working with the Tishman Environment and Design Center.

    Michael holds a BS in Evolutionary Anthropology from Rutgers University, and an MS in Environmental Policy & Sustainability Management from The New School.

  • Roles and Responsibilities

    Michael Klein is the Director of Research Compliance.  His work focuses on research compliance issues such as conflict-of-interest and research misconduct.

    Biography

    Before joining Columbia in July 2008, Mr. Klein served for three years as senior attorney with the New York State Task Force on Life and the Law, the state’s interdisciplinary bioethics commission.  He also has held legal positions with the U.S. Department of Health and Human Services and the law firm Simpson Thacher & Bartlett.  Mr. Klein graduated from Columbia Law School in 1999.  Before entering law school, he received an M.A. in science writing from the Johns Hopkins University. 

  • Meral Karakoc, PharmD, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Melissa Vega is a Budget Analyst with the Clinical Trials Office. She is responsible for determining financial feasibility and negotiating directly with pharmaceutical companies to ensure compliance with University policies and procedures.

  • Melanie Sola, MA, is a Manager of Finance and Special Projects at the Clinical Trials Office. Melanie provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center. She is also responsible for the training of colleagues and assisting in the development of account receivable strategies.

  • Roles and Responsibilities

    Matt is responsible for the Executive Vice President's calendar, office website, events, and communications.

  • Having joined Columbia University on August 1, 2011, Dr. Mary Jo Shepherd is currently Executive Director of the Office of the Institutional Animal Care and Use Committee (IACUC). Dr. Shepherd has responsibility for assuring the University’s compliance with all laws, regulations and guidelines pertaining to the care and use of laboratory animals.  Dr. Shepherd received her B.S. and D.V.M. from the Ohio State University and practiced small animal medicine for almost 20 years.  

    She entered the laboratory animal field in 1988 and was a member of 5 IACUCs for a number of years while working at a privately owned medical device testing laboratory.  She has been employed at two pharmaceutical companies and another large academic institution.    

    Mary Jo has been active in Public Responsibility in Medicine & Research (PRIM&R) by serving on the IACUC conference Planning Committee and by serving as faculty for workshops and panels.  She has been active in the American Association for Laboratory Animal Science (AALAS) at the local and national levels and is currently serving on AALAS’s Editorial Review Board.  She was actively involved in the planning of the New Jersey Association for Biomedical Research’s (NJABR) annual IACUC seminar for over ten years.  Dr. Shepherd was also on the Americans for Medical Progress Board of Directors for 5 years.  

  • Marta Scotto, RPh, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • IRB Specialist

  • Marley Bauce is the Manager of Research Initiatives within the Office of the Executive Vice President for Research. In this role, he is responsible for the Research Initiatives in Science & Engineering (RISE) competition, multiple limited submission competitions, event planning, internal communications, publishing and branding, administrative support of the Shared Research Computing Policy Advisory Committee (SRCPAC), supervision of casual employees, and multiple special projects designed to advance and fund the University's research enterprise.

    Prior to joining Columbia in 2014, Marley was the Manager of the Blavatnik Awards for Young Scientists within the Blavatnik Family Foundation, where he was responsible for competition design, executive communications, and customer support for university leadership and faculty and postdoctoral nominees. He held an integral role in the expansion of the program from a regional to national competition. Marley additionally currently serves as an adjunct associate professor of environmental studies, philosophy, and history at Pace University, focusing in animal ethics, food ethics, and sexuality ethics.

    Marley holds an MA in the Environmental Studies from NYU, an MS in Publishing from Pace University, and is currently working towards an Executive MPA in Columbia University's School for International and Public Affairs (SIPA).

  • Maritza Pardave-Martinez is the Clinical Trials Administrator with the Clinical Trials Office. Maritza provides document services to the Columbia University Medical community by managing the contract routing process and maintaining the contract repository.

  • Marilyn Morris, MD, MPH, is the Medical Director of the Clinical Trials Office.

  • Manal Saad, RPh, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Magaly Garcia, MD, is the Director of the Spanish Translation Center. She coordinates all aspects of the translation and review of documents at Columbia University and outside institutions to be used by Hispanic participants in research. 

  • Luis Garcia is a Senior Contract Specialist with the Clinical Trials Office. He negotiates and finalizes an array of research related agreements on behalf of the research community at P&S. Luis also advises faculty and staff on applicable laws and institutional policies governing human subjects research. In addition, Luis manages the confidentiality agreement process.

  • Lucy Liu, PharmD, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Luciann Greco is the Research Pharmacy Administrative Coordinator. She is responsible for Research Pharmacy billing, purchasing, accounts payable, accounts receivable, human resources, and other administrative duties pertaining to Research Pharmacy.

  • Lourdes Fernandez is the Director of Budgets at the Clinical Trials Office. She is responsible for the management and oversight of all industry sponsored clinical projects to ensure accuracy and financial feasibility while adhering to the University's policies and procedures.

  • Kinara Yang, PharmD, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Kathleen Anne Crowley, PA-C, MPH, DrPH is Associate Vice President, Environmental Health and Safety for Columbia University. She holds both an MPH and a DrPH from Columbia University Mailman School of Public Health (MSPH) in the Environmental Health Sciences Department. Before joining Columbia University, Dr. Crowley worked at NewYork Presbyterian Hospital fulfilling various positions including Director of Occupational Health Services and Senior Physician Assistant. Since 2005, she has served as an active member of the Mailman School of Public Health Alumni Board of Directors, and is the immediate past president (2013-2016). Dr. Crowley is a member of the MSPH Governance Committee which includes selection of the annual Allan Rosenfield Alumni Award and the Outstanding Recent Alumni Award. Dr. Crowley is the founding editor of the E-Mailman, the Newsletter of the MSPH Alumni Association. Other MSPH alumni activities she has been involved include: student mentorship, fostering alumni relations, fundraising, Presenter at Admitted Students Day (NYC), Closing Commencement Speaker, and Moderator at the Alumni Summit. Dr. Crowley is proud to be a member of the Columbia Alumni Association (CAA) Women’s Leadership Advisory Group, including participation as a panelist for Women Leading Change, Columbia Alumni Leaders Weekend (2016) and co-chair of the University’s inaugural Women’s Conference, “She Opened the Door” to be held February 2018. She is also an active member of the CAA 2023 Task Force and CAA Strategic Planning Committee. Dr. Crowley values her education at Columbia University and enjoys collaborating with other schools across the University.

  • Jonathan Kim, MBA, is the Associate Director of Finance and Business Operations of the Clinical Trials Office. Jonathan is responsible for the management and oversight of the financial and business operations of the Office of Research Administration, which encompasses Sponsored Projects Administration (SPA) and the Clinical Trials Office (CTO).

  • Roles and Responsibilities

    Joel Roselin is the Assistant Director of Research Compliance Education. His work focuses on creating educational programs on research compliance and research ethics for the Columbia research community, including faculty and staff, students, and post-doctoral research fellows.

    Biography

    Before joining Columbia, Mr. Roselin was Program Specialist in medical ethics at the Department of Veterans Affairs National Center for Ethics in Health Care. Prior to VA, he spent six years as the Director of Public Programs in the Harvard Medical School Division of Medical Ethics. Mr. Roselin is a former fellow in medical ethics at Harvard Medical School and has a degree in ethics from the Harvard Divinity School.

  • Jessenia Hernandez is a Financial Analyst at the Clinical Trials Office. Jessenia provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center.

  • Jennifer Rojas, CPhT, is a Research Pharmacy Coordinator. She signs out and delivers study medication and conducts site qualification visits and interim monitoring visits in addition to managing drug inventory and pharmacy supplies ordering.

  • Roles and Responsibilities

    Janique's work focuses on matters relating to export controls, international research, and conflict-of-interest.

    Biography

    Ms. Cheesman received her Bachelor of Science in Environmental Engineering from Syracuse University in 2012. She then went on to complete a Master of Science in Sustainable Engineering from Villanova University. Before coming to Columbia, Ms. Cheesman worked as a consultant for two years on projects involving environmental health and safety, environmental compliance, and corporate sustainability.

     

  • Jane Cho, MS, MPH, is the Manager of Regulatory Science at the Clinical Trials Office. She is responsible for the management and oversight of the CTO’s regulatory science unit, which is comprised of the IND/IDE Assistance Program (IAP), the Clinical Research Coordinator (CRC) Training Program, and the Clinical Trials Monitoring Assistance Program (CTMAP). 

  • Jack Pearsons, CPhT, is the Research Pharmacy Administrative Manager. He reviews new study submissions for feasibility, provides written cost estimates for Research Pharmacy services, and supervises Pharmacy Coordinators and Pharmacy Technicians.

  • Hisham Elsayed is a Research Pharmacy Coordinator. He signs out and delivers study medication and conducts site qualification visits and interim monitoring visits in addition to managing drug inventory and pharmacy supplies ordering.

  • Helen Kim, PharmD, is the Executive Director of the Clinical Trials Office. She manages and supervises the budget and the staff in the Clinical Trials Office who are responsible for assisting investigators in preparing applications, negotiating contracts, setting up sub-award arrangements and maintaining certain post-award/contract functions, in addition to overseeing the operations of CUMC's research pharmacy. 

  • Greg Culler is the Associate Director of Research Initiatives within the Office of the Executive Vice President for Research, and is responsible for the limited submission internal selection process, internal communications, donor relations, and website development.

    Prior to joining the Office, Greg was a Project Manager in the Columbia University Libraries' Center for Oral History, previously working as a Consultant in Fortress Investment Group.

    Greg holds an MA in East Asian Languages and Cultures from Columbia University, and a BA in East Asian Studies and Anthropology from Arizona State University.

  • Roles and Responsibilities

    The Executive Vice President for Research has overall responsibility for the University's research enterprise, encompassing a broad spectrum of research departments, institutes and centers in the natural and biomedical sciences, the social sciences and the humanities. Columbia has a long and distinguished history of discovery of new knowledge. The Office of the Executive Vice President for Research works to foster the continuation of those creative endeavors and to promote an environment that sustains the highest standards of scholarship, health and safety.

  • IRB Specialist

  • Elnaz Anjom, PharmD, is the Research Pharmacy Director. She oversees the day to day operation of research pharmacy to ensure safe and effective patient care in addition to planning, organizing, and implementing Standard Operating Procedures (SOPs) in accordance with institutional policies and procedures and in cooperation with other departments while following Good Clinical Practice (GCP), FDA and JCAHO requirements.

  • Elizabeth Mo, PharmD, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Eliana Cardona is a Financial Analyst at the Clinical Trials Office. Eliana provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center.

  • Donalrey Nieva, CPhT, is a Research Pharmacy Coordinator. He signs out and delivers study medication and conducts site qualification visits and interim monitoring visits in addition to managing drug inventory and pharmacy supplies ordering.

  • Diana Kim, MPA, is a Regulatory Science Specialist at the Clinical Trials Office. She assists in overseeing the Clinical Trials Office’s regulatory compliance and providing assistance to the research community at P&S in the development and conduct of clinical trials.

  • Delia Wu is the Senior Undergraduate Fellow of Research Initiatives within the Office of the Executive Vice President for Research. In this role, she is responsible for benchmarking Columbia's performance against peer institutions, authoring articles on novel research for various publications, managing a database of faculty research award recipients, helping maintain office websites, event planning, and assisting with internal communications.

    Delia is a senior in Columbia College, double majoring in Economics and Psychology. Outside of her role within the Office, Delia is French horn section leader for the Columbia Wind Ensemble, a tutor for Community Impact, and a resident advisor.
     

  • Role and Responsibilties

    Deborah Stiles is currently the Vice President for Research Operations and Policy, and Chief Operating Officer in the Office of the EVP for Research, a position she has held since 2004, when the Office of the Executive Vice President for Research was established.  As the Vice President for Research Operations and Policy, she manages nine University-wide offices that constitute the backbone of Columbia’s $1 billion research enterprise.  These operations include grants and contract processing, the clinical trials office, human and animal research review boards, postdoctoral affairs, environmental health and safety and the animal facilities.  With the Executive Vice President for Research, she has been responsible for consolidating and restructuring these operations and improving business processes to increase efficiency and develop better client service to the research community.  In addition, she initiated the formation of offices for research compliance and training and research initiatives.

    Biography

    Prior to joining Columbia, Ms. Stiles was a corporate partner at the international law firm, Debevoise & Plimpton, having joined the firm as an associate in 1976.  At Debevoise, she was head of the firm’s Finance Practice Group and had extensive experience in its finance and private funds practices.  She was an associate at Cleary, Gottlieb, Steen & Hamilton from 1974-1976.

    Ms. Stiles received her B.A. from Radcliffe College, magna cum laude, in 1969, where she was elected to Phi Beta Kappa.  She received her J.D. from Harvard Law School, cum laude, in 1974.

    Ms. Stiles is a member of the Dean’s Council of the Radcliffe Institute for Advanced Study.  She is a member of the Board of Directors of The Collegiate Chorale.  She is also a member of the Board of Directors of New York Small Business Venture Fund LLC and New York Small Business Venture Fund II & III LLC that invest in economic development projects in New York City. Ms. Stiles is also a member of the Council on Foreign Relations.

  • Roles and Responsibilities

    Cynthia is responsible for the Vice President for Research Operations's calendar and communications. She manages the human resources and administrative responsibilities for the Office.

  • Connie Eng, PharmD, is a Research Pharmacist. She provides essential investigational drug services to investigators and research personnel according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements of FDA and JCAHO. Investigational Drug Services include but are not limited to: dispensation, inventory management, communication with clinical team, communication with study sponsors, sterile compounding of hazardous and non-hazardous agents, creating study specific pharmacy guidelines, handling of on-call studies and conducting Site Initiation Visits (SIV), Close Out Visits (COV) and Monitor Visits (MV).

  • Collin Glidewell, JD, LLM, is the Associate Director of Contract Negotiations with the Clinical Trials Office. He manages the workflow of the Senior Contract Specialists and Clinical Trial Administrator, and oversees the contract negotiation and execution process within the Clinical Trials Office. 

  • Cindy Han is a Regulatory Science Specialist at the Clinical Trials Office. She assists in overseeing the Clinical Trials Office’s regulatory compliance and providing assistance to the research community at P&S in the development and conduct of clinical trials.

  • Roles and Responsibilities

    Carmen Nieves is the Coordinator in the Office of Research Compliance and Training, providing support to RCT’s conflict of interest, export control and research misconduct activities, as well as our many training programs.

    Biography

  • Role and Responsibilities

    Brenda is the Executive Director of the Human Research Protection Office / IRBs and is responsible for ensuring that research involving human subjects, including behavioral research (e.g., surveys) and biomedical investigations (e.g., clinical trials), is conducted ethically and in a manner that promotes compliance with all applicable ethical and regulatory requirements.

    Biography

    Brenda has been at Columbia University since 2003. She previously served as the Interim Executive Director (since 2013). From 2004-2012, Brenda served as Associate Director, Institutional Review Board and prior to that, she served as Administrative Coordinator (2003-2004). Before joining Columbia University, she served as Sponsored Programs Administrator at Rutgers, The State University of New Jersey from 2000-2003. Her earlier career includes positions at UMDNJ – Robert Wood Johnson Medical School, J&J Temporaries and CCR Electronics, Inc. Brenda received her B.A. in Liberal Studies from Thomas Edison State College.

  • Roles and Responsibilities

    Barbara Szolc is the Compliance Specialist in the Office of Research Compliance and Training, helping to manage the administration of the University’s policies and processes concerning conflict of interest in research.

    Biography

    Dr. Szolc received an M.D. from University of Lodz, Poland, and  completed her postdoctoral training in biomedical science at Northwestern University and Columbia. She was also part of the NASA Space Radiation Exploration Program (NSRSS) in 2007. Dr. Szolc has published many scientific papers in peer-reviewed journals including J. of Rad. Bio., J Vasc Interv Radiol, Magn Reson Med., Radiology, Radiation Research, Nanomedicine and Gastroenterology. Her research was mostly focused in radiation biology, immunology, neurology and social science. Prior to returning to Columbia, Dr. Szolc worked at New York University in education management, providing oversight and monitoring of pre-doctoral academic administration.

  • Ayala Schwartz, JD, is a Senior Contract Specialist with the Clinical Trials Office. She negotiates and finalizes an array of research related agreements on behalf of the research community at P&S. Ayala also advises faculty and staff on applicable laws and institutional policies governing human subjects research.

  • Anely Ninonuevo is the Executive Assistant of the Clinical Trials Office. She provides executive level support for the Associate Vice President of the Office of Research Administration and the Executive Director of the Clinical Trials Office, coordinates meetings and conferences, performs personalized and confidential administrative duties, and interfaces with senior and administrative staff members and a wide array of University and Hospital offices, faculty members, and government agencies.

  • Roles and Responsibilities

    Anderson Smith is the Administrative Manager for the Office of Research Compliance and Training. He is primarily responsible for day-to-day office operations and finance management.

    Biography

     

  • Alicia Baksh-Ousman is a Financial Analyst at the Clinical Trials Office. Alicia provides investigators and their research teams financial accounts receivable services, including ARC account creation and changes, invoicing and reconciliation of industry-sponsored clinical trials at Columbia University Medical Center.

  • Adnan Khan is a Budget Analyst with the Clinical Trials Office. He is responsible for determining financial feasibility and negotiating directly with pharmaceutical companies to ensure compliance with University policies and procedures.

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