Candidate Information Title Clinical Research Operations Target Location US-FL-Boynton Beach	20,000+ Fresh Resumes Monthly     View Phone Numbers     Receive Resume E-mail Alerts     Post Jobs Free     Link your Free Jobs Page     ... and much more Register on Jobvertise Free
Search 2 million Resumes Keywords: City or Zip:	Related Resumes Clinical Research Trials Miami, FL Medical Writing Clinical Research Oakland Park, FL Clinical Research Trials Palm Beach Gardens, FL Senior Clinical Research Associate Boynton Beach, FL Medical Assistant Clinical Research Boynton Beach, FL Clinical Research Trials Port Saint Lucie, FL Clinical Research Nurse Manager Deerfield Beach, FL

OBJECTIVE:I am an accomplished and performance-driven clinical research professional with >Street Address  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 timeExcellent communications skills and team builder, and mentorQuality and Compliance leadership, ensuring site audit readiness at each siteOutstanding networking and relationship skillsOperational knowledge and proficiency of GCP/ICH in site management, monitoring and complianceExceptional recruitment and retention strategist, with focus on diversity and equity in clinical trialsExperienced clinical research and site management trainer, and mentorProficient in Microsoft Office, Medidata RAVE, Velos, m-CTMS, SharePoint, and VTMF systemsTHERAPEUTIC AREA EXPERTISE:Oncology-Solid Tumor and hematology, and bone marrow transplant, including phases I-IV, palliative care, and preventionNeuropsychiatry: Alzheimers disease, Bipolar, SchizophreniaUrological cancers and other urology disease, set up Phase I sperm centerPROFESSIONAL EXPERTISE:Nancy Nahmias Consulting, LLC Jan 2023  PresentAccepting 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 2023Sylvester Comprehensive Cancer CenterUniversity of MiamiProvided 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 2019Northwell Health Monter Cancer InstituteDirects 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 RoundsSenior Site Manager, Oncology, Janssen Research and Development, LLC June 2013 - June 2017Conduct site selection, pre-study assessments, site initiation, and training of all site staff.Conduct regular monitoring visits per study monitoring plan; identify issues, and presentsolutions 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 inplace to ensure patient completes the trial.Function as the Lead, SM and worked with internal teams to ensure that study needs are metCRA III, Senior Lead CRA, Point Person, Sanofi-Aventis NACSU Jan 2009 to May 2013Oversee 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 & customizedmonitoring tools; i.e. monitoring plans, eCRF guidelines, generate essential CRA update, andmaintain internal FAQ documentsPresent at Investigator meetings and support project management during meetingsDevelop strategic recruitment plans for sites. Share feedback with corporate teams on strategiesto increase active sites and subjectsSupport quality to avoid unnecessary queries, communicate data quality trends and highlight common issues.Conduct territory development in cnojunction with regional medical liaisons to develop newoncology sitesResponsible for clinical monitoring of multiple Phase I, II & III clinical trial sites, in oncology,Alzheimers disease, and diabetes.RCRA  Oncology Point Person, Sanofi-Aventis NACSU 2008-2009Regional Clinical Research Associate, Sanofi-Aventis NACSU 2007-2008Director, Clinical Research Office, Connecticut Urological Research 2005-2007Grove Hill Medical Center, New Britain, CTSite 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 1999-2010Specialized in feasibility, training, recruitment, and retention programs for multiple priority projects in neuroscience (Alzheimers, 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 submissionBudget and contract negotiationClinical Trials Specialist, Oncology Franchise, Ortho Biotech, Inc. 1997-1998Consulted 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 transplantFacilitated discussions about clinical research and off-label use of productsAssisted in development of Phase IIIb program for $2 billion productTargeted research projects and investigators at oncology scientific meetings for grant funding.Senior Clinical Affairs Specialist, Ortho Biotech, Inc. 1996-1997Consulted with key opinion leaders, designing protocols from concept to completionMonitored Phase I-IV studies for post-marketed productsManager, Clinical Research Office, Yale Cancer Center 1995-1996Yale University Medical School, New Haven, CTManaged Clinical Research Office (CRO) with supervision of ten study coordinators.Created standard operating procedures for integrating the use of the CRO by all research facultyDeveloped 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 programDeveloped and implemented GCP and SOP training program for clinical research staffWorked with senior director of the cancer program to expand Yale Cancer Center network.Clinical Trials Coordinator, University Cancer Center 1991-1995University of Connecticut Health Center, Farmington, CTCoordinated 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 trialsClinical Research Associate, Clinical Cancer Research 1987-1990Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CTClinical Research Assistant, Clinical Cancer Research 1986-1987Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CTResearch Study Assistant, Hematology-Lymphoma Services 1983-1986Memorial Sloan-Kettering Cancer Center, New York, NYEDUCATION:MSW Degree Candidate, University of CT, School of Social Work 2003-2006BA  Community Health Education, Queens College, City University of New York 1983CERTIFICATIONS:ACRP CCRA Certification, October, 2008, renewed 2012, 2014, 2016PROFESSIONAL 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. 115-121ABSTRACTS: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, 19865.N. Nahmias. J. Sanchez. A. Olier-Pino. A. Allred. K. Aviles. L. Corrales: Successful Methodsof Addressing Clinical Research Staff Turnover. Association of American Cancer InstitutesProgram (July 12-24, 2022 First Place Abstract with poster presentation.NAME CHANGE:10/88: Nancy Nahmias Gerber06/97: Nancy Nahmias Persky04/06: Nancy NahmiasTHERAPEUTIC EXPERIENCE:Oncology: 38+YearsOvarian  15 years (Lead) I, II, IIIProstate  8 years (Lead) I, II, IIILung  4 years (Lead) II, IIIBreast  7 yearsBladder  2 yearsNon-Hodgkins Lymphoma  10 years, I, II, III, IVMultiple Myeloma  2 years, I, IICervical  2 years (Lead), Phase IColorectal  1 year, Phase IIIPediatric Brain Tumor  1 year (Lead)BMT in NHL and Breast, Phase IVPhase I LLM, Solid TumorNeuroscience: 14 YearsAlzheimers Disease  14 years, IIBipolar Disorder  4 years, IIISchizophrenia  4 years, II