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CLINICAL RESEARCH ASSOCIATE I Resume Example

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CLINICAL RESEARCH ASSOCIATE I
Professional Experience
CLINICAL RESEARCH ASSOCIATE I
February 2010 to December 2012Regeneron Pharmaceuticals, Inc － Tarrytown, NY
  • Supported Clinical Trial Managers (CTMs) with site issues and assist with site management for ongoing studies Acts as a secondary point of contact for contract research organizations (CROs), vendors and investigative sites regarding site issues and study conduct Responsible for collecting and tracking study start-up site regulatory documents Ensured site enrollment and other study specific documents are updated and maintained in WATSON-CTMS Assisted with collating and distributing Site Regulatory Binders and Study Manuals to investigative sites Tracked monitoring visits and report visit completion to CTMs Assisted in the preparation and review of protocols, Informed Consent Forms (ICFs), eCRFs (electronic Case Report Forms), study manuals, and other study documents as requested by the Clinical Trial Manager Assisted CTM with writing and reviewing study specific documents (e.g.
  • Protocols, ICFs, Source Docs, etc) Accompanied Clinical Research Associates (CRAs)/Clinical Trial Managers (CTMs) on co-monitoring visits at investigator sites Reviewed and reconciled the Trial Master File Managed and maintained the Clinical Program SharePoint and share drive Responsible for RCRC submission on behalf of CTMs and attend applicable meetings Transcribed and distribute weekly team meeting minutes.
CLINICAL TRIAL COORDINATOR Clinical Trial Leader/Clinical Trial Manager
August 2007 to January 2010MannKind Corporation － Paramus, NJ
  • Assisted Clinical Trial Managers (CTMs) with site management activities from study start up to study closeout Submitted regulatory documents to investigational sites (e.g.
  • Clinical Trial Agreements, FDA 1572 forms, Financial disclosure forms, Protocols, Investigator's Drug Brochure (IDB), and CV templates) Collected, tracked and reviewed incoming regulatory documents for completeness, accuracy, clarity and legibility prior to site initiation and drug release Responsible of submitting site documents to central institutional review board (IRB) for approval Assisted with assembling and distributing Regulatory Binders and training materials to study sites Entered, maintained and updated study tracking information into clinical trial management system (CTMS) Reviewed contracts and budgets associated with clinical trial agreement and ensure site/vendor payments are reviewed and process efficiently and accurately Responsible for ordering and tracking clinical study supplies Interface with vendors, investigators and contract research organization (CROs) to ensure quality and timelines are met Reviewed monitoring visit reports, record all issues and discrepancies onto spreadsheet and submit to CTM for resolution Ensure Confirmation/Follow-Up letters are present in all study site files Worked in conjunction with the Field Monitor to manage and oversee study sites Assisted Data Management with data clarification resolution, missing Case Report Form pages, Adverse Events/Serious Adverse Events reconciliation and review patient profiles for accuracy prior to database lock Communicated all relevant and critical issues to upper management Provided weekly and cumulative status reports on assigned projects.
CLINICAL TRIAL ASSISTANT
April 2005 to August 2007MannKind Corporation － Paramus, NJ
  • Provided administrative support to the Clinical Study Team which includes word processing, photocopying, scanning, tracking, filing, record keeping and report generation Responsible of coordinating and scheduling internal/external meetings (i.e., Investigator Meetings, end of study meetings, team meetings, etc.) Organized, collated and distributed clinical research training manuals and binders to Investigator's Meetings Assisted with execution of site and vendor contracts Communicated and worked closely with Clinical Trial Coordinator to update site contact information Assisted Clinical Research Associates (CRAs) with site identification/selection of potential investigators Prepared mass mailings and airway bills for express mail couriers Responsible for quality record retention according to GCP/ICH guidance and internal standard procedures Responsible for maintenance and tracking all study related documents and materials Reviewed and approved central lab specification and other trial specific documents Distributed investigational new drug (IND) Safety notification to study investigative sites and central/local institutional review board/Ethnic Committees Assisted Data Management with QC of patient profiles and data entry prior to database lock.
RESIDENTIAL COUNSELOR
February 2003 to September 2006YAI/NIPD Young Adult Institute/National Institute － New York, NY
  • Assisted clients' with personal hygiene by giving bedpans, urinals, shampooing hairs, and shaving facial hair; assisted clients to the bathroom and aiding with showers and baths Assisted clients with their activities of daily living by serving their meals, feeding clients as necessary; ambulating, turning, and positioning patients; providing fresh water and nourishment between meals Participated in scheduled events & activities Observed clients for appropriate behaviors & solving problems Administered medications and treatments to clients as prescribed by the physician Documented actions by completing forms, reports, logs, and records Provided direct and supervision care to clients with developmental disabilities Prepared meals, iron and wash clothes to assigned clients Escorted clients out of the building during fire drills Accompanied clients to hospital/emergency room visits as needed Assisted clients in the completion of chores and assigned tasks Participated & collaborated in team meetings regarding client issues.
CLINICAL PROJECT ASSISTANT
September 2003 to October 2004Bio-Analytical Research Corporation (BARC) Lab － Lake Success, NY
  • Provided central operations support to the clinical project team, including performing functions such as: coordination, maintenance & management of multiple clinical trials (Phases I - IV) Entered patient demographics into database; daily review of subject data to ensure errors and inconsistencies are not present prior to database lock; generate and resolve existence Data Clarification Form (DCF) queries Faxed and transmitted hardcopy (NCR) lab reports to investigational sites and/or CRA (Clinical Research Associates); file lab reports in study specific binders accordingly Tracked & ordered study supplies; assist with assembling & distributing study lab kits to sites; prepare and transport laboratory specimens to Central Laboratory for analysis Serves as a central contact for designated project communication; resolve clinical trial operation discrepancies via phone and/or email communication Assisted Project Management with special projects such as validating lab reports and specification Trained employees in database utilization and provided new hires with appropriate orientation Attended local investigator and project specification meetings as needed.
Education and Training
Medical Research Management *Writing Professional Monitoring Reports : October 2011Orange County Community College
CRA & CRC Roles & Responsibilities - Beginner, June 2006 *Conducting Clinical Trials Under ICH GCP : November 2005
Phlebotomy Certificate : May 2015
Barnett International Educational Services *FDA Requirements for Sponsor to Report Fraud, February 2011 *Monitoring Clinical Drug Studies : May 2009
Associate of Science : Nursing, December 2017Orange County Community CollegeNursing
Bachelor of Arts : Social Science, August 2003Adelphi UniversitySocial Science
Skills
administrative support, Brochure, budgets, Clinical Research, clinical study, clinical trials, contracts, client, clients, data entry, Data Management, database, developmental disabilities, email, filing, Financial, Forms, GCP, IND, letters, materials, Meetings, mail, SharePoint, Phlebotomy, positioning, Project Management, Protocols, quality, express, record keeping, regulatory documents, Research, Safety, scanning, scheduling, specification, spreadsheet, supervision, phone, training materials, training manuals, word processing
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Resume Overview

Companies Worked For:

  • Regeneron Pharmaceuticals, Inc
  • MannKind Corporation
  • YAI/NIPD Young Adult Institute/National Institute
  • Bio-Analytical Research Corporation (BARC) Lab

School Attended

  • Orange County Community College
  • Adelphi University

Job Titles Held:

  • CLINICAL RESEARCH ASSOCIATE I
  • CLINICAL TRIAL COORDINATOR Clinical Trial Leader/Clinical Trial Manager
  • CLINICAL TRIAL ASSISTANT
  • RESIDENTIAL COUNSELOR
  • CLINICAL PROJECT ASSISTANT

Degrees

  • Medical Research Management *Writing Professional Monitoring Reports : October 2011
    CRA & CRC Roles & Responsibilities - Beginner, June 2006 *Conducting Clinical Trials Under ICH GCP : November 2005
    Phlebotomy Certificate : May 2015
    Barnett International Educational Services *FDA Requirements for Sponsor to Report Fraud, February 2011 *Monitoring Clinical Drug Studies : May 2009
    Associate of Science : Nursing , December 2017
    Bachelor of Arts : Social Science , August 2003

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