OBJECTIVE:

I am an accomplished and performance-driven clinical research professional with >35 years of proven expertise in both the pharmaceutical, and academic arenas working in clinical research.

HIGHLIGHTED QUALIFICATIONS:

Strong leadership skills in project and people management leading cross-functional teams to ensure study endpoints are met on time

Excellent communications skills and team builder, and mentor

Quality and Compliance leadership, ensuring site audit readiness at each site

Outstanding networking and relationship skills

Operational knowledge and proficiency of GCP/ICH in site management, monitoring and compliance

Exceptional recruitment and retention strategist, with focus on diversity and equity in clinical trials

Experienced clinical research and site management trainer, and mentor

Proficient in Microsoft Office, Medidata RAVE, Velos, m-CTMS, SharePoint, and VTMF systems

THERAPEUTIC AREA EXPERTISE:

Oncology-Solid Tumor and hematology, and bone marrow transplant, including phase’s I-IV, palliative care, and prevention

Neuropsychiatry: Alzheimer’s disease, Bipolar, Schizophrenia

Urological cancers and other urology disease, set up Phase I sperm center

PROFESSIONAL EXPERTISE:

Nancy Nahmias Consulting, LLC Jan 2023 – Present

Accepting roles in oncology clinical research; Audit preparation, Quality review, Clinical Monitoring, Study Management, Resource Management, Recruitment Specialist, Study Start-up, Grant Writing. Vast experience with global vendor management, and global teams.

Executive Director, Clinical Research Services Jan 2020 – Jan 2023

Sylvester Comprehensive Cancer Center

University of Miami

Provided oversite and strategic direction in the continual assessment of 7+ network sites, and approximately 100+ staff, and make recommendations for organizational improvements to senior leadership.

Ensure internal control oversight and compliance with FDA and GCP regulations, meeting recruitment timelines, compliance with university policies and procedures, reliability of internal and external reporting, and efficiency and effectiveness of operations.

Identified and develop systems for enhancing department efficiency. Created process to ensure audit readiness, and quality guidelines.

Oversee the analysis of protocols to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements, and IP labeling requirements.

Worked with clinical operations staff to achieve established project goals within the expected time frames; decreasing time to activation and FPI.

Maintained a high level of professional expertise through familiarity with clinical literature and attendance at professional meetings.

Supported professional development of staff and created a highly desired work environment by attracting and retaining highly qualified clinical operations professionals.

Administrator of NCI P30 Addendum, Catch-up 2020 grant. Ensure accrual metrics are met, and expand NCI early phase portfolio to ensure inclusion of our diverse catchment area.

Expansion and award of the ETCTN network trials due to our success with the Catch-up 2020 grant.

Senior Administrative Director, Center for Novel Cancer Therapeutics June 2017 – August 2019

Northwell Health Monter Cancer Institute

Directs and oversees development and operational management of cancer clinical research including industry, federal, and grant projects. Managed 36 employees; 12 research nurses, 12 study coordinators, 6 regulatory staff, 3 research finance staff, investigational pharmacist, and two research lab coordinators. This includes clinical research performed at 6 sites that are part of our research network.

Oversee 5-year NCI NCORP grant; successful grant renewal of $4.6 mil for additional 6 years.

Assist investigators to write investigator-initiated trials, and submission of IND to FDA; arrange pipeline presentations from industry, and federal agencies.

Oversees all phases of grants management including informational, financial and budgetary management; strategic and long-term planning; and oversight to support the daily research operational goals of the Cancer Institute.

Coordinates resources to achieve the goals of clinical research within the Cancer Institute.

Ensures quality and compliance with operational performance of department and all related entities.

Ensures audit readiness amongst all research staff and projects.

Teach auditing techniques and audit readiness to all site disease groups.

Develops support systems for clinical trial referrals, patient, and business management including budgeting and staffing.

Supports revenue cycle functions and quality excellence initiatives.

Speaker at various venues on clinical research in cancer; Susan G. Komen NYC, Leukemia and Lymphoma Society, National Ovarian Cancer Coalition (NOCC), Monter Cancer Center Grand Rounds

Senior Site Manager, Oncology, Janssen Research and Development, LLC June 2013 - June 2017

Conduct site selection, pre-study assessments, site initiation, and training of all site staff.

Conduct regular monitoring visits per study monitoring plan; identify issues, and present

solutions to study team for follow-up to resolution.

Lead Diversity and Inclusion work stream for developing site networks within areas with diverse demographics, train site managers on how to work with medical field personnel to develop new diverse research sites.

Conduct new hire training, and act as a mentor for new site managers.

Work with sites to ensure patient recruitment efforts are documented, and retention plans are in

place to ensure patient completes the trial.

Function as the Lead, SM and worked with internal teams to ensure that study needs are met

CRA III, Senior Lead CRA, Point Person, Sanofi-Aventis NACSU Jan 2009 to May 2013

Oversee study feasibility, and provide feedback to the clinical project leader.

Identify potential study issues early in development to provide proactive talking points for CRAs.

Train internal staff on site management, coordinate development of essential & customized

monitoring tools; i.e. monitoring plans, eCRF guidelines, generate essential CRA update, and

maintain internal FAQ documents

Present at Investigator meetings and support project management during meetings

Develop strategic recruitment plans for sites. Share feedback with corporate teams on strategies

to increase active sites and subjects

Support quality to avoid unnecessary queries, communicate data quality trends and highlight common issues.

Conduct territory development in cnojunction with regional medical liaisons to develop new

oncology sites

Responsible for clinical monitoring of multiple Phase I, II & III clinical trial sites, in oncology,

Alzheimer’s disease, and diabetes.

RCRA – Oncology Point Person, Sanofi-Aventis NACSU 2008-2009

Regional Clinical Research Associate, Sanofi-Aventis NACSU 2007-2008

Director, Clinical Research Office, Connecticut Urological Research 2005-2007

Grove Hill Medical Center, New Britain, CT

Site Director for clinical investigator site, specializing in urology and oncology.

Managed 9 employees, creating infrastructure for growth into additional therapeutic areas.

Business growth specialist focusing on networking with sponsors, CROs, and other research sites to increase business network. Site projects grew from 5 studies to 20 within 6 months with active recruitment.

Created Standard Operating Procedures and Quality Assurance program to ensure data quality.

Negotiate research budgets and contracts.

Create strategic recruitment plans for each clinical trial to optimize enrollment. Negotiate with media to provide optimal recruitment advertisements for minimal cost.

RecruitMedia-Recruitment Vendor, and Project Management Consultant 1999-2010

Specialized in feasibility, training, recruitment, and retention programs for multiple priority projects in neuroscience (Alzheimer’s, Bipolar, and Schizophrenia) and oncology (cancer pain, prostate cancer).

Project Manager of all awarded projects. Interface and hold CRO accountable for all milestones.

Project Manager and monitor for Phase 1 trials in ovarian and cervical cancer, including protocol development and CRF design for Australian pharmaceutical company.

Conducted data review of in-licensed colorectal compound in preparation for NDA submission

Budget and contract negotiation

Clinical Trials Specialist, Oncology Franchise, Ortho Biotech, Inc. 1997-1998

Consulted with thought leaders, designed protocols from concept to completion, negotiated and monitored clinical protocols from Phase I-IV, negotiated grants and contracts for physician IND studies in ovarian, lung, breast cancer, and bone marrow transplant

Facilitated discussions about clinical research and off-label use of products

Assisted in development of Phase IIIb program for $2 billion product

Targeted research projects and investigators at oncology scientific meetings for grant funding.

Senior Clinical Affairs Specialist, Ortho Biotech, Inc. 1996-1997

Consulted with key opinion leaders, designing protocols from concept to completion

Monitored Phase I-IV studies for post-marketed products

Manager, Clinical Research Office, Yale Cancer Center 1995-1996

Yale University Medical School, New Haven, CT

Managed Clinical Research Office (CRO) with supervision of ten study coordinators.

Created standard operating procedures for integrating the use of the CRO by all research faculty

Developed and implemented systems for data management functions.

Coordinated all NIH and FDA audits, contracts, budgets, and research agreements.

Designed a CRF and IRB tracking system and trained users on program

Developed and implemented GCP and SOP training program for clinical research staff

Worked with senior director of the cancer program to expand Yale Cancer Center network.

Clinical Trials Coordinator, University Cancer Center 1991-1995

University of Connecticut Health Center, Farmington, CT

Coordinated all sponsor, ECOG, and NSABP clinical research studies.

Managed audits and completed case report forms. Interviewed and trained new research staff.

Wrote protocols, prepared IRB applications, informed consent, progress reports, and toxicity data. Prepared and submitted IND applications to FDA for PI initiated trials.

Designed database for Julie Merle Epstein Ovarian Cancer prevention Clinic and prepared data for analysis and publication in conjunction with Northwestern Medical Center.

Administered budgets grant applications, lab and pharmacy agreements, and grants for academic, and pharmaceutical company trials

Clinical Research Associate, Clinical Cancer Research 1987-1990

Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT

Clinical Research Assistant, Clinical Cancer Research 1986-1987

Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT

Research Study Assistant, Hematology-Lymphoma Services 1983-1986

Memorial Sloan-Kettering Cancer Center, New York, NY

EDUCATION:

MSW Degree Candidate, University of CT, School of Social Work 2003-2006

BA – Community Health Education, Queens College, City University of New York 1983

CERTIFICATIONS:

ACRP CCRA Certification, October, 2008, renewed 2012, 2014, 2016

PROFESSIONAL ASSOCIATIONS:

Association of Clinical Research Professionals (ACRP)

American Society of Clinical Oncology (ASCO)

PUBLICATIONS:

1.Nahmias – Persky N, Wilson E, Devine N, Donohue A, and Montgomery C: Nursing Home Trials and Tribulations, ACRP Monitor, Sept. 2005.

2.Berman E, Arlin Z, Gaynor J, Miller W, Gee T, Kempin S, Mertelsmann R, Andreeff M, Reich L, Nahmias N, Clarkson BD: Comparative Trial of Cytarabine and Thioguanine in Combination with Amsacrine or Daunorubician in Patients with Untreated Acute Non-Lymphocytic Leukemia: Results of the L-16M Protocol. Leukemia, Vol. 3, No. 2, February 1989 pp. 115-121

ABSTRACTS:

1.Arlin Z, Berman E, Gee T, Kempin S, Mertelsmann R, Andreeff M, Nahmias N, Clarkson BD: Results of a Comparative Trial in Amsacrine and Daunorubicin in Combination with Cytarabine and Thioguanine in Patients with Untreated Acute Non-Lymphocytic Leukemia: Results of the L-16M Protocol. Am Soc Hematol Journal, December 1984.

2.Berman E, Arlin Z, Gee TS, Kempin SJ, Nahmias N, Andreeff M, Clarkson BD: Results of a Comparative Trial of Amsacrine, Cytarabine/Thioguanine (AAT) and Daunorubicin, Cytarabine/Thioguanine (DAT) in Patients with Untreated Acute Non-Lymphocytic Leukemia (AANL): Results of the L-16M Protocol. 3rd European Conference on Clinical Oncology Proceedings, June, 1985.

3.Haines I, Andreeff M, Mertelsmann R, Chaganti R, Nahmias N, Clarkson BD: Prognostic Factors in Primary Myelodysplastic Syndrome (PMDS). American Society of Clinical Oncology, Vol.5; 165, March, 1986.

4.Schwartzberg L, Nahmias N, Gee T, Andreeff M, Clarkson BD: Treatment of Central Nervous System (CNS) Relapse in Adult Acute Lymphoblastic Leukemia (AAL). American Society of Clinical Oncology, Vol.5; 160, March, 1986

5.N. Nahmias. J. Sanchez. A. Olier-Pino. A. Allred. K. Aviles. L. Corrales: Successful Methods

of Addressing Clinical Research Staff Turnover. Association of American Cancer Institutes

Program (July 12-24, 2022 First Place Abstract with poster presentation.

NAME CHANGE:

10/88: Nancy Nahmias Gerber

06/97: Nancy Nahmias Persky

04/06: Nancy Nahmias

THERAPEUTIC EXPERIENCE:

Oncology: 38+Years

Ovarian – 15 years (Lead) I, II, III

Prostate – 8 years (Lead) I, II, III

Lung – 4 years (Lead) II, III

Breast – 7 years

Bladder – 2 years

Non-Hodgkin’s Lymphoma – 10 years, I, II, III, IV

Multiple Myeloma – 2 years, I, II

Cervical – 2 years (Lead), Phase I

Colorectal – 1 year, Phase III

Pediatric Brain Tumor – 1 year (Lead)

BMT in NHL and Breast, Phase IV

Phase I LLM, Solid Tumor

Neuroscience: 14 Years

Alzheimer’s Disease – 14 years, II

Bipolar Disorder – 4 years, III

Schizophrenia – 4 years, II

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