clinical research associate i resume example with 9+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - - : - -
Professional Summary
Highly motivated Sales Associate with extensive customer service and sales experience. Outgoing sales professional with track record of driving increased sales, improving buying experience and elevating company profile with target market.
Skill Highlights
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Professional Experience
02/2010 to 12/2012
  • 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.
08/2007 to 01/2010
CLINICAL TRIAL COORDINATOR Clinical Trial Leader/Clinical Trial Manager Talis Biomedical Reno, NV,
  • 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.
04/2005 to 08/2007
  • 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.
02/2003 to 09/2006
RESIDENTIAL COUNSELOR Principia Biopharma Inc. Grand Rapids, MI,
  • 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.
09/2003 to 10/2004
CLINICAL PROJECT ASSISTANT Bio-Analytical Research Corporation (BARC) Lab City, STATE,
  • 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
Expected in October 2011 to to
Medical Research Management *Writing Professional Monitoring Reports:
Orange County Community College - ,
Expected in November 2005 to to
CRA & CRC Roles & Responsibilities - Beginner, June 2006 *Conducting Clinical Trials Under ICH GCP:
- ,
Expected in May 2015 to to
Phlebotomy Certificate:
- ,
Expected in May 2009 to to
Barnett International Educational Services *FDA Requirements for Sponsor to Report Fraud, February 2011 *Monitoring Clinical Drug Studies:
- ,
Expected in December 2017 to to
Associate of Science: Nursing
Orange County Community College - ,
Expected in August 2003 to to
Bachelor of Arts: Social Science
Adelphi University - ,
Social Science
Community Service
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

School Attended

  • Orange County Community College
  • Orange County Community College
  • Adelphi University

Job Titles Held:

  • CLINICAL TRIAL COORDINATOR Clinical Trial Leader/Clinical Trial Manager


  • Medical Research Management *Writing Professional Monitoring Reports
  • CRA & CRC Roles & Responsibilities - Beginner, June 2006 *Conducting Clinical Trials Under ICH GCP
  • Phlebotomy Certificate
  • Barnett International Educational Services *FDA Requirements for Sponsor to Report Fraud, February 2011 *Monitoring Clinical Drug Studies
  • Associate of Science
  • Bachelor of Arts

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