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Click here or scroll down to respond to this candidate1Candidate's Name
EMAIL AVAILABLE PHONE NUMBER AVAILABLE Brooklyn, NYCAREER OVERVIEWAccomplished Research Leader and Military Veteran with over a decade of experience in Public Health Service leadership. Committed to clinical research development, strategizing, planning and innovation. Work well in collaborative teams and has a proven record of fostering relationships and managing diverse objectives. QUALIFICATION HIGHLIGHTS Research Design (Qualitative & Quantitative) Analytical and critical thinking skills Global Research Initiatives Project Management Oncology, HIV/AIDS, Mental Health Research Reports, Presentations and Manuscripts Program Development/Evaluation Supervision & Mentorship Phases I-IV Written/Verbal CommunicationPROFESSIONAL EXPERIENCEClinical Research Manager, 07/ 2018 08/2020 (Oncology) Columbia University Medical Center, New York, NY Regulatory Compliance: Assisted with compliance training initiatives, including coordinating educational sessions, writing and editing compliance manuals and developing presentations.Maintained current and working knowledge of federal, state and local regulations, institutional policy and proceduresDeveloped materials and processes to support researchers Staff Management & Training: Supervised the training/development and performance management for direct and indirect reports in the department.Led compliance training initiatives, including coordinating educational sessions, writing and editing compliance manuals and developing presentations. Protocol Development: Lead aspects of the protocol development process including preparing protocols, consent and other essential study document review. Financial Management: Work closely with the appropriate partners, forecast trial resource needs, and assess staffing resource needs for program and senior leadership to ensure appropriate line function allocations Clinical Trial Reporting: Generate protocol portfolio status reports for key partners. Implement solutions for streamlining and accelerating the monitoring and review of clinical trials to significantly increase accrual to clinical trials, data cleaning, data quality, and trial completion. Quality Assurance: Participate and ensure preparedness in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Developed Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP. Develop study timelines and ensure adherence; escalates concerns/issues related to timelines to senior management appropriately. Lead clinical trial team meetings and contributed to clinical updates to cross-functional project team meetings. Project Manager (various therapeutic areas), 09/2017 07/2018 BioTrial Inc., Newark, NJ Provided customer-focused leadership and project oversight. Proactively solved issues, and oversaw the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations. Managed and coordinated the activities of clinical trials with the Biotrial Project Team. Served as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.2 Developed study timelines based on protocols. Ensured project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials. Lead the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. Followed screening and recruitment activities to ensure timely enrollment in studies. Organized and coordinated Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members. Monitored and ensured that project scope and deliverables were fulfilled within timelines and budget. Collaborated with Billing and Accounts Department to ensure billing with pre-established milestones. Reviewed and approved Vendor/Site contracts, budgets and invoices. Organized sponsors' visit of the Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits) Lead Clinical Trials Associate (Remote, Oncology), 09/2014 03/2017 Merck/PRA Health Sciences, Raleigh, NC Served as a Subject Matter Expert for the Clinical Operations team. Amplified set-up and maintenance of study systems including but not limited to Clinical Trial Management System(CTMS), Trial Master File (TMF) etc. Facilitated and contributed to study level lessons learned Ensured compliance with the clinical trial registry requirements Provided input into baseline budget development and management. Provided input into timeline development and management Executed clinical trial tasks efficiently for assigned studies Assist with oversight of clinical study by tracking CRO and third-party vendors activities Managed vendor(s). Coordinated contract and budget review to meet study deliverables Collaborated with study team to develop site tools, as well as clinical trial documents, including informed consent forms, monitoring plans, protocols and amendments, and other documents, as required Assisted with budget oversight by tracking site payments and vendor invoices in collaboration with finance and study team Provided general logistical support for clinical trials, such as creating agendas and taking minutes at meetings, preparing for investigator meeting, and assisting with purchasing Clinical Research Associate (Psychiatry/Oncology), 01/2014 08/2015 PAREXEL International, RTP, NCPerform investigator site pre-study site qualification visits including collection of site regulatory documents Lead site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions (including follow through to ensure successful outcome) Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug Participated in/lead the Investigator/Initiation Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to conduct the study safely and accurately in line with protocol requirements Assisted in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.) Monitored recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication Maintained project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment Identified and completed follow- up of SAEs at study sites, Assisted with data listing, data coding, patient profile reviews, database lock, and site close-out activities Ensured appropriate and timely submission of documents to the Trial Master File 3Protocol Review & Monitoring Project Coordinator (Oncology), 09/2010 8/2013 NYU Cancer Institute, New York, NY Lead and facilitated the Cancer Institute Protocol Review and Monitoring System review process. Coordinate and implement the operations of the NYU two clinical research oversight committees - the Scientific Review and the Feasibility Committees. Reviewed and managed review committee and IRB requests under the guidance of the Chair Planned and conducted for-cause audits to ensure adherence to local and federal requirements. contains up-to-date and accurate information regarding external IRB reliance studies for reporting, quality, and oversight purposes. Served on internal subcommittees, e.g. policy subcommittee, and ongoing process improvement. Synthesized and analyzed data collection of NYUs cancer clinical trials for accuracy, reliability, and verifiability for compliance with all institutional and federal regulations. Guided quality and efficiency in conducting clinical trial; astute of compliance with regulatory, documentation, and oversight requirements. Developed department SOPs/guidelines, in accordance with ICH-GCP and other applicable local and international regulations. Developed metrics/reports to monitor strategic goals & initiatives for functional areas of: Data and Safety Monitoring Committee (DSMC), for-cause audit, Clinicaltrials.gov compliance and investigator initiated regulatory requirements. Advised investigators and research staff of PRMC review status updates. Disseminated letters, memos and correspondence regarding study submission status. Liaised with senior leadership Clinical Operations team to ensure deliverables (timeline, quality, productivity) were meet. Maintained PRMS records in the Info-Ed/CTMS database and prepared reports for committee meetings from this database. Reviewed and provide input into patient recruitment plan and retention plan for low accruing studies. Senior Clinical Research Coordinator/Outreach Coordinator (Psychiatry), 12/2004 12/2010 Duke University Medical Center/Durham Veterans Affairs Medical Center, Durham, NC Psychiatry (Mental Illness Research Education Clinical, Centers (2004-2008)Coordinated projects in the department of Psychiatry, as part of a collaboration between Duke & the Veterans Administration.Promoted and fostered relationship with the Veterans Administration programs and faith-based coalitions. Lead board and medical staff meetings to educate, influence and promote cohesion.Oversaw all aspects of various research studies under the direction of the Principal Investigator at the Mental Illness Research Education & Clinical Centers (MIRECC) department. Evaluated Mental Health related research policies and interpreted clinical data. Lead collaboration efforts with stakeholders to build alliance.Conducted structured diagnostic interviews for OEF/OIF Combat Veterans diagnosed with PTSD, MTBI and Schizophrenia, including participant screening, recruitment and retention. Administered structured, scripted diagnostic and clinical assessments to include the MINI International Neuropsychiatric Interview (M.I.N.I.), Clinician Administered PTSD Scale for DSM-IV (CAPS), Traumatic Brain Injury Screening (TBI) assessments.Reviewed journals, abstracts and scientific literature to keep abreast of new developments Immunology/Infectious Diseases Therapeutic Area (2008-2010)Coordinated projects overseeing established guidelines in the collection of clinical data and/or administration of clinical studies.Managed and coordinated the day-to-day activities of infectious diseases studies, enrolled, and screened patients. Implemented educational programs and prevention program in HIV/AIDS initiatives.Devised social/behavioral HIV/AIDS research interventions (medication adherence for pediatric patients). Participated in clinical studies conducted by principal investigator(s) including, but not limited to, grant funded research and/or industry sponsored clinical trials conducted on site at duke university medical center or its affiliated sitesPerformed a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. Supervised the work of research assistants. Followed established guidelines in the collection of clinical data 4and/or administration of clinical studies.Prepared material for IRB submission including study summaries and consent documents.Conferred with study participants to explain purpose of study and obtain informed consent; explain diagnostic procedures and/or treatment plans to alleviate patient and/or family concerns; scheduled patient for study visits; initiated/coordinated drug and laboratory orders.EDUCATIONDoctor of Social Work, Capella University 2020Project Management Certificate, Project Management Institute 2016Master of Social Work University of North Carolina at Chapel Hill; Chapel Hill, NC 2010Bachelor of Social Work/Psychology, Meredith College; Raleigh, NC 2004 AWARDS2009 IPA, Awarded by VA Medical Center (Psychiatry & Behavioral Sciences, Translational Neuroscience) 2005 Children Affected by AIDS Foundation Grant, GSK (Child Adherence to Antiretrovirals) LEADERSHIP & COMMUNITY SERVICEVolunteers of AmericaUnited States Navy VeteranNational Association of Social WorkersNetwork for Social Work ManagersNational Association of Healthcare Executives |
