Lisa Celi Stein

954-***-****

ad2n8z@r.postjobfree.com

Summary

• Clinical Research/Operations Professional

• Over 19 years of Research Management experience, including but not limited to Phase I, II, III, IV, Trauma, Pediatric, Geriatric, Oncology, Diabetes, Cholesterol, Vaccines, Cardiology, Hypertension, Asthma, Humanitarian Use Devices (HUD's), Retrospective chart review studies, etc.

• Restructuring of all ongoing studies, including in-house audits

• Oversight of Hospital IRB (Institutional Review Board)

• Develope and maintaing SOP's (Standard Opersting Procedures) for both Research and the IRB

• Responsable for updating and maintaining corporate policies, reviewing changes through the IRB, FRC and the governing board

• Medical backround include EMS (EMT-Paramedic)

• Excellent interpersonal relationships with medical staff, researchers, patients, CRO’s and study sponsors. Knowledge and experience as lead coordinator in study start-up to study close-out.

Skills

Main Focus: Ability to restructure research department operations and work flows. Creating an infastructure and reorganizing job descriptions and duties which will adhere to the proper SOP's, Policies and Procedures as well as abiding by the FDA rules and regulations.Clinical trial developement, clinical operations, managing and assigning curriculum appropriate to the site and the role. Track data and metrics related to training and compliance. Serve as representative for audits and corrective and preventative actions (CAPA) including collaberation with cross-functional partners to ensure preparedness for audits. Trial start-up packages to close-out visits.CRF's and protocol review, data collection ( Inform, RAVE, Medidata etc.)

A Positive team player

Professional Experience

St Mary’s Medical Center/ West Palm Beach, FL

Trauma Research Operation Coordinator Dec. 2019-Sep. 2021

Coordinating the finances of Trauma Research (Trauma/METRC, Independent Physicians Research, Tenet, etc.) from initial process of contract negotiation to approval of contracts. Works with Corporate Director of research to get individual study approval (regulatory and financial) through Ecats. Maintains and updates financial summary and reports are given quarterly and as requested. Manages the initiation and process of all clinical trials according to FDA/GCP regulatory and institutional guidelines. Oversee and train clinical research personnel. Responsable for all aspects of state trauma standards pertaining to research requirements. In charge of all documentation and data colection for all retrospective chart reviews.

Metrowest Medica Center (Tenet Hospital)

Research Auditor Dec. 2018-Sep. 2019

• Auditing of all current and past clinical trials to ensure regulatory compliance

• Restructuring of research department work flows

• Management and overseeing of Physicians and Coordinators training and responsabilities

• Assist in day to day support of study status, milestones and performing quality check activities across components of the clinical trials

St Mary’s Medical Center/Children’s Hospital

West Palm Beach, Florida March 2013-May 2018

• Instituted and overseeing of a Facility Research Committee (FRC) which is composed of a multidisciplinary group of representatives from all areas of the hospital to be informed and included in Clinical Research projects.

• Restructuring of all Children’s Oncology Group Studies including an in-house audit to obtain permission to continue with patient enrollment.

• Obtaining Trauma Protocols with the Department of Defense (DOD) to aid the hospital in becoming a Level One Trauma Center

• Oversight of in-house IRB, ultimately transitioning all of our studies, as well as our sister hospital studies to Metrowest Institutional Review Board.

• Regulatory: From Start Up-package to Close-Out visit

• Financials: Including creating site budgets for individual protocols along with invoicing and tracking payments.

• Monitor study activities to ensure compliance with protocols as well as local, federal and institutional policies.

• Assessment of study distribution to site staff, along with protocol training.

University Clinical Research

Pembroke Pines, Florida

Clinical Trial Manager 2007-2011

• Monitor and supervise Research Coordinators as well as Lab Techs.

• Conduct weekly meetings to review recruitment/recruitment goals

• CRF and Protocol Review, Data Collection (Inform, RAVE, Medidata, Clinical Conductor)

• Staff Protocol Training

• Establishing and conducting SIV”s as well as Monitoring Visits

• Supervising Regulatory Documents as well as maintaining correspondence with Sponsor’s CRO’s and IRB’s

• Supervising the staff//records prior to FDA Audits (Always for high enrollers)

• Management: Managed all site staff needs.

Discovery Clinical Research

Plantation, Florida

Clinical Research Coordinator 2001-2007

• Planned, organized and conducted research studies from start-up to close-out

• Executed daily operations of all clinical protocols, planned and scheduled subject visits according to protocol guidelines

• Developed recruitment plans for each individual study

• Trained all participating Physicians, Nursing Staff, Radiology and Laboratory personnel for each study

• Maintained Regulatory Binders/Updated documents

• Completed all SIV’s, Monitoring Visits and Close-out visits

• Collected and recorded data into source documents as well as RDC (RAVE, Oracle, Inform and Medidata)

• Attended Investigator meetings along with PI/Sub Investigator

Atlantic/Lifefleet/AMR

Delray Beach, Florida

EMT-Paramedic 1989-2001

Education

EMS, Medical Arts Training Center, Margate, FL EMS Degree: EMT/Paramedic 1987-1991

Bessilar Research Institute, WPB, FL Research Operations, CCRC/CRA 1992-1996

Certificates

• IATA

• GCP

• CITI

• NIH

• CCRC

• OSHA

• ACRP

References Available Upon Request

Responsible for the overnight monitoring of research subjects participating in a clinical trial. Will also assist with data entry and research related tasks. Knowledge of good clinical practices and responsible conduct of research preferred. CPR certification preferred but will train qualified applicants. Reports to the Director and/or Lab Manager.

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