Tammy Manchester, RN, BSN

Experience

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  Allen Bennett Hospital

  Jun 1994 - Dec 1997

  Staff Nurse

  Responsibilities - Management and care of medical/surgical and pediatric patients.

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  Upstate Clinical Research

  Jan 1995 - Jan 1996

  Study Coordinator

  Responsibilities - Coordination of inpatient and outpatient clinical trials.

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  Carolina Multi-Specialty Associates

  Jan 1996 - Jan 1998

  Registered Nurse

  Strategic and organizational planning for practice; assessment, triage and education of practice patients.

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  Radiant Research

  Mar 1999 - Oct 2001

  Lead Coordinator/IRB Regulatory Specialist

  Responsibilities - Management of regulatory documentation including the submission and maintenance of regulatory documentation. Coordination of inpatient, outpatient and psychiatric clinical trials.

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  Progressive Research

  Oct 2001 - Feb 2003

  IRB Specialist / Research Manager

  Responsibilities - Management of regulatory documentation including informed consent development. Coordination and management of inpatient, outpatient and pain trials for pharmaceutical research, regulatory training new employees, development of SOPs.

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  Lutheran hospice

  Oct 2001 - Jun 2003

  Case Manager

  Responsibilities - Coordination of care of terminally ill patients and their families

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  Greenville Hospital System

  Feb 2003 - Jul 2008

  Clinical Research Manager - Department of Medicine

  • Developed the Clinical Trials Research Program for the Department of Medicine• Conducted pharmaceutical and device trials• Therapeutic Areas: Medicine, Surgery, Orthopedic, Infectious Disease, Critical Care, Endocrinology, Gerontology and HIV• Directly managed the research staff• Developed and implemented educational programs and training for research professionals• Developed an internal QA program• Monitored the conduct of clinical trials, subject safety, regulatory requirements, and protocol compliance• Performed GCP audits. Developed corrective and preventive action plans to address deficiencies• Research contracts and budgets. IRB Submissions, consent form development• Managed sponsor visits, prequalification, initiation, interim and close-out visits• Initiated and managed regulatory documentation including informed consent development• Performed investigational drug and device management• Clinical Research SOP development. Show less

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  Albert Einstein College of Medicine

  Jan 2008 - Jan 2010

  Quality Assurance Coordinator - Committee on Clinical Investigations

  • Conducted routine GCP audits and HIPAA compliance reviews for pharmaceutical studies focusing on Oncology trials. • Reviewed allegations of research noncompliance, including issues related to the protection of human subjects and research billing concerns• Developed written processes for compliance with applicable regulations• Developed and implemented education and training for the research community• Developed CAPA plans to address noncompliance• Provided support for investigator-initiated studies, pre-reviewed investigator initiated studies • Reviewed adverse events and protocol violations in preparation for IRB review• IRB Submissions, consent form development. Show less

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  North Shore Long Island Jewish Health System

  Mar 2011 - Jun 2012

  CRA/Manager, Research Compliance - Office of Research Compliance

  • Monitored the conduct of clinical trials at local and national sites including: Site Identification and evaluation, development of study tools, CRFs and data collection worksheets, conducted initiation visits, interim monitoring visits, source documentation verification, maintained the regulatory files, assessing the conduct of the research, maintaining the monitoring schedule, documenting monitoring findings, accountability of investigational product, site training for modifications and amendments. Data review and source verification.• Developed monitoring program to ensure compliance with FDA regulations, GCP and institutional policies• Performed pharmaceutical drug GCP routine and for cause GCP audits. Prepared written report of findings• Developed CAPA plans to address deficiencies and secure compliance• Assisted with the interpretation of Federal and State regulations and quality standards for the institution• Gathered material and developed presentations to inform institutional research policies and procedures to enhance quality and mitigate risk• Provided support to the research community through research education• Non-voting member of the Institutional Review Board. Show less

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  North Shore-LIJ Health System

  May 2011 - Oct 2013

  Assistant Director, Clinical Research, Oncology

  • Monitored Cooperative Group (NCI) Clinical Trials• Oversaw regulatory, clinical and data management activities for pharmaceutical and compassionate use drugs (approximately 200 studies)• IRB Submissions, consent form development• Therapeutic Areas: Solid Tumor and Hematology, Palliative Care • Performed GCP audits and QA reviews. Developed corrective and preventive action plans (CAPA) to address deficiencies• Prepared for and managed sponsor and cooperative group audits. Responded to audit findings.• Data collection, abstraction and source document verification and submission of clinical data, addressed queries• Trained Research Professional on research requirements including: GCPs, Federal, local and institutional policies.• Developed SOPs and research processes to support research compliance, efficiency and improve workflow• Protocol development, start-up and monitoring of investigator initiated trials• Directly managed a staff of 25 research professionals• Performed investigational drug management• Managed the Scientific Review Committee (review of Investigator Initiated Trials). Assisted in the development of Investigator Initiated Trials. Show less

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  Long Island Plastic Surgical Group

  Jan 2013 - Jan 2014

  Director of Clinical Research

  • Oversee the Clinical Trials Research Program, pharmaceutical, surgical and device trials• Therapeutic areas: Burn, Surgical, Pain Assessment, Anti-infective, Vascular Trials and Cosmetic Trials• Clinical Trial Budget and Contract Negotiations for pharmaceutical, device and investigator initiated trials• IRB Submissions, consent form development• Direct management of staff including time and attendance and performance reviews• Investigator Initiated Trial Development• Staff training (GCP, Federal Research Regulations)• Study Start-up, interim monitoring and study close-out activities.• Quality Assurance, Clinical Trial SOP Development• Data collection, abstraction and source document verification and submission of clinical data, addressed queries• Investigational drug and device management. Show less

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  Allergan

  Jan 2014 - Jan 2015

  Clinical Trial Manager

  FDA Audit preparation of the TMF including the general and site files for domestic and international clinical trials. Support the Senior Clinical Trial Manager/Operational Study Lead, managed various aspects of the operational execution and delivery of quality studies, vendor management, and quality control activities (e.g., quality checks and balances to ensure inspection readiness, enrollment, metrics, milestones, timelines, and budget).

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  Boehringer Ingelheim

  Mar 2015 - Dec 2016

  Regulatory Document Manager

  • Managed the regulatory workflow from pre-initiation through close-out for oncology, CNS and Respiratory clinical trials and translational research studies (investigator developed trials that are sponsored by BIPI)• Developed project level Informed Consent Forms for clinical trials• Ensured that appropriate regulatory documentation is collected in preparation for investigational product release• IRB submission and tracking of sponsor level documents• Ensured the quality of regulatory document prior to submission to TMF• Reviewed TMF documents to ensure audit readiness• Management of Regulatory Document Reviewer team• Oversaw the organization and preparation of regulatory submissions and all applicable documentation• Provided regulatory expertise to cross functional teams• Ensured timely start-up and maintenance of critical documents• Developed and presented metrics and study status to cross-functional team. Show less

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  Immunomedics

  Dec 2016 - Mar 2018

  Clinical Research Associate

  • Conduct routine on-site monitoring visits for solid tumor research protocols• Perform on-site data verification, verify supporting source documentation from the medical record and the research chart• Verify that the data, queries and site records are accurate, legible, contemporaneous, original, accurate, complete, and meets quality standards• Communicate with research staff, Principal Investigator, and the sponsor.• Review subject information for eligibility to participate in solid tumor oncology trials• Verify that the investigators and study personnel are conducting the study in accordance with the IRB approved protocol, GCP, local and federal regulatory requirements to ensure protection and ethical treatment of human research subjects• Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB• Ensure accountability of Investigational Product are accurate and complete and that necessary study supplies are in place• Ensure complete reporting and proper documentation of monitoring activities and the site’s progress• Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness• Prepare and approve site budget payments and invoices• Trial Master File maintenance and reconciliation• Ensure regulatory documents are complete. Review and revise informed consent forms. Show less

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  Cipla

  Mar 2018 - Feb 2023

  Project Manager/CTM/CRA, Cipla Ltd.

  Provided Project Management support to the Clinical Research and Development Group including:o Management of 103 sites. (US)o Oversight of CRO, CRAs.o Site liaison for sponsor, site and CRO.o Review reports and documents from Clinical Research Organization’s (CRO) and CRO staff (examples Including: Interim Monitoring Visit reports, Site Qualification reports, Site Initiation Reports, Close-out visit reports and site start-up packages.)o Vendor oversight which includes visits to research sites to evaluate CRO and site performance and quality of work. o Participated in vendor and CRO selection.o Oversaw the Trial Master File for accuracy and completeness prior to transfer from the CRO to the sponsor.o Site deviation review, sponsor and site Standard Operating Procedure review and assessment. o Sponsor Oversight Plan development (Site and CRO oversight for performance and quality of work. (development, implementation, training, and issue tracking).o Development performance/quality metrics for CRO, monitors, and site performance. o Created, disseminated, and maintained documentation of observations and findings relating to the above.o Developed, implemented and performed inspection readiness activities.o Participation in team meetings to provide updates on the responsibilities, findings, and observations.o FDA Inspection Preparation: Provide site preparation, support, and participated in FDA site inspections.o Perform site qualification visits and study start-up activities.o CRA for smaller respiratory trials. Show less

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  Weill Cornell Medicine

  Jun 2021 - Jun 2022

  Compliance Manager

  Audit and Education Program• Direct Management of 5 staff members• SOP, Investigator site guidance, educational tool, Audit Plan, and process development• Performs full-scope audits of research sites, develops CAPA Plans, education of PI/Research Team regarding deficiencies. • Provides oversight, support and guidance to the PI and Study Staff for investigator-initiated trials. • Performs/Oversees central registration of research participants• Performs GCP audits and supportive training for cancer research• Development of Corrective/Preventive Action Plans (CAPA)• Developed and maintained quality metrics to identify trends. Show less

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  Spruce Biosciences

  Feb 2023 - Mar 2024

  Clinical Trial Manager

  Manages European sites. (Denmark, Germany, Ireland, Netherlands, Spain, and the United Kingdom)o Review reports and documents from Clinical Research Organization’s (CRO) from feasibility through closureo Reviews and approves Greenlight prior to drug shipment, ICFs, RA/EC approvals)o Manages monitoring report review quality o Assist in vendor management (CRO, vendors)o Tracking and communication of subject status, recruitment, site vendor issues.o Site quality oversight visitso CRO Oversight Visits • eTMF filing and systematic review of the Trial Master file.• Develop processes to promote efficiency and quality. Show less