Highly skilled Project Manager with more than [Number] years working in cross-functional environments in the U.S. and abroad. Exceptional written and oral communication skills.
Quality assurance and control
Unsurpassed work ethic
Unsurpassed work ethic
Work flow planning
Quality Control ManagerJul 2014 to Current Elite Research Institute － Miami Gardens, FL
Prepares and manages the execution of the Quality Control Plan (QC) for each study.
Reviews and approves draft source documents and study schedules to ensure that they are in alignment with the protocol, site SOPs, and GCP Reviews and verifies screening charts for validity and accuracy of Inclusion/Exclusion criteria, ICF documentation process and PI review.
Ensures all source documents are reviewed and have undergone quality control standards as required by the QC Plan.
Reviews study day records ensuring that data collection is complete, and consistent with the protocol requirements and principles of good documentation.
Documents and ensures QC findings are addressed timely with a resolution prior to data entry.
Reports protocol deviations identified during QC activities.
Conducts verification of source data to electronic Case Report Forms as outlined in the QC Plan.
Meets with clients to discuss any issues with protocol, any protocol deviations, and reports consistent QC findings to PI and Senior Director, Clinical Operations.
Establishes deadlines for queries resolutions and takes necessary measures to ensure they are met.
Performs a QC review of the Regulatory Binder at study completion, prior to archiving.
Analyze the nature and cause of errors to identify areas needing improvement within the department's process and systems.
Serves as a liaison with staff and management concerning error trends and problem areas.
Assists with site audits including, internal, sponsor, and FDA.
Responsible of planning and conducting quality control (QC) activities to determine compliance of data with protocols, site Standard Operating Procedures (SOP), and Good Clinical Practice (GCP).
Key leadership role with focus on continuous improvement efforts using approved tools to ensure the quality of studies at Elite Research Institute.
Clinical Operations ManagerJan 2014 to May 2014 Phase One Solutions, Inc － Miami Gardens, FL
Prepared internal timelines and ensured all CSR deliverables were met within those and our external study timelines.
Assumed the responsibility of final quality control review of all source documents and completed CRFs prior to sponsor submission Performed final protocol and ICF reviews for IRB submissions Collaborated in regulatory activities, including the timely submissions of multiple studies for IRB approval Monitored for proper AE/SAEs reporting to regulatory entities and sponsors.
Maintained, planned and had oversight of inter-departmental communications.
Initiated and had oversight of proper staff training.
Monitored staff compliance with GCP and GDP regulations.
Manager, Clinical Data ManagementSep 2011 to Dec 2013 Watson Therapeutics, Inc CCD a CRO － Miramar, FL
Designed, developed and created study specific database and edit specifications Managed the design, deployment and lock of study databases.
Responsible for foreseeing the key aspects for data management planning and reporting to ensure clean, accurate, and quality-reviewed data.
Case Report Forms design and review.
Developed, managed, and implemented edit checks and coding specification documentation.
Performed coding activities.
Developed Data Management Plans, Data Entry Guidelines and Data exports of locked data Managed the query resolution process Performed database freeze and lock procedures and completed corresponding documentation Provided operational assistance in support of and as member of the Data Management, Clinical Services and Corporate office teams.
Certified Clinical Research CoordinatorSep 2008 to Sep 2011 University of Miami － Miami, FL
Dept of Neurology - Epilepsy, Parkinson's and Stroke studies Managed the study conduct of all epilepsy studies Responsible for the preparation and submission of protocols, consents and other supporting documentation to central and local IRBs.
Submissions included protocol amendments, safety reports, protocol deviations, continuing reports, study closures and all other necessary regulatory documentation Paper CRFs and eCRF data entry.
Created and prepared source documents for studies as needed.
Assisted the Principal Investigator with identification and selection of appropriate study patients through chart reviews, referrals and clinics.
Created and submitted feasibility budget reports and contracts to our Clinical Trials Initiatives Services Office (CRIS) Responsible for the pre-screening, screening, and enrollment of patients Coordinated the functions of the different departments as required per protocol.
Managed several projects including the implementation and training of Velos created to facilitate milestones tracking, invoicing and the creation of calendars for all clinical trials in every division in Neurology.
Responsible for the compliance and training of all research coordinators and accounting personnel for this new system.
Performed all laboratory processes and shipment.
Responsible for the receipt and storage of all study drugs and lab kits for all studies.
Drug dispensation through IVRS system.
Clinical Research CoordinatorJan 2008 to Jun 2008 Pediatrix Medical Group － Sunrise, FL
Responsible for the submission of protocols, informed consents, and essential documents for each site participating in a clinical trial.
Reviewed research protocols for appropriateness, clarity, required elements, human subject protection issues and researchcompliance.
Created and maintained master spreadsheets that included participant lists, IRB approval and consent approvals, and essential documents for each site participating in a clinical trial.
Responsible for acting as the Administrator and/or Query User for the electronic case report form, and for testing scripts for one or more trials.
Clinical Study Assistant IISep 2005 to Jul 2007 Abbott Laboratories Kos Pharmaceuticals, Inc － Weston, FL
Maintained budget spreadsheet for each clinical trial and coordinated payments with Director and the Accounting Department.
Performed Internal Audits - reviewing files for completeness of documentation, i.e., regulatory documents, protocol approvals, monitoring report-visit dates as instructed by Director of Research.
Designed and maintained a monitoring tracking report for all sites visits for all offsite contracted Clinical Research Associates.
Prepared, administered and evaluated training program qualification tests for contracted Clinical Research Associates and determined SOP compliance.
Senior Administrative AssistantOct 2004 to Aug 2005 TEVA Pharmaceuticals, Inc － Miami, FL
Successfully planned and completed an Investigators' Meeting with an attendance of over fifty participants for Ivax Pharmaceuticals.
Liaison between investigators and the legal department for the execution of confidentiality agreements, clinical trial agreements, service agreements, consulting agreements and all other legal documentation necessary for the initiation and/or continuance of clinical trials.
Education and Training
Associate of Science, Business Administration1992Queensboro Community College － Bayside, NY, USA
Associates, BusinessJune 1992Business
ESOL1988Hunter College － New York
ACRP CCRC, Certification Clinical Research Coordinator2010ACRP