Jessica Claire
, , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - - -
Professional Summary

Enthusiastic Senior Clinical Research Associate eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of good clinical practice.

  • 6+ years of site management experience.
  • Experience working with multi-functional project teams.
  • Computer literacy, including spreadsheet, database and word processing applications.
  • Knowledge of ICH and local regulatory authority regulations regarding drug.
  • Experience in monitoring all trial components (PSSV to COV).
  • Ability to travel as needed (greater than 70%).
  • Excellent attention to detail.
  • Excellent communication skills.
  • Experience working in phases I-III clinical trials.
Work History
03/2021 to Current
Senior Clinical Research Associate Nova Biomedical Atlanta, GA,
  • Works independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
  • Assists with submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
  • Participates in preparing and reviewing study documentation and feasibility studies for new proposals as required.
  • Manages sponsor generated queries efficiently and responsible for study cost effectiveness.
  • Assists in training and mentoring less experienced CRA's.
  • Provides support to Project Team and Clinical Operations Team.
  • Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.
  • Serves as primary contact for assigned research sites.
  • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
  • Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
  • Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verifies the rights and well-being of trial subjects are protected.
  • Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
  • Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
  • May support translations of essential documents.
  • May support submission of trials to IRB/IEC and regulatory authorities.
  • Verifies that written informed consent was obtained before each subject’s participation in the trial.
  • Verifies that the investigator is enrolling only eligible subjects.
  • Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
  • Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
  • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Verifies and supports the recording and reporting of adverse .
01/2019 to 03/2021
Clinical Research Associate II Danaher Grand Island, NE,
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
  • Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
11/2016 to 01/2019
Clinical Research Associate I Covance Charleston, WV,
  • Conducted patient data monitoring for accuracy and protocol compliance.
  • Conducted site qualification, initiation and site closeout visits and complete all appropriate documentation related to the visits.
  • Provided support in site recruitment Support in the compiling and analysis of patient data.
  • Obtained/reviewed/processed regulatory and administrative documents from investigative sites.
  • Liaised with sites to ensure sufficient study drug is available for clinical activities.
  • Requested sites to return unused study drug and upon arrival review for shipment integrity.
  • Reviewed documentation of blood samples/specimens and tumor slides submitted by sites.
  • Maintained inventory of clinical supplies and ship to sites as needed Other duties as assigned.
01/2014 to 11/2016
Clinical Research Data Coordinator Northwest Hospital South, WA,
  • Performed all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) were achieved.
  • Performed reconciliation of the clinical database against safety data, laboratory data and other third-party data.
  • Reviewed clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raised queries to resolve erroneous, missing, incomplete or implausible data.
  • Generated, resolved, and tracked queries to address problematic data identified during data review activities and apply proper modification/correction to the database.
  • Ran ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trials.
  • Interacted with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as necessary.
  • Created and reviewed data listings.
  • Assisted with creation/review of edit checks.
  • Created dummy data to test edit checks and to test database screen.
  • Assisted in creation of Study Test Plan and Study Test Report.
  • Performed database decommissioning and create supportive documentation.
Expected in
Bachelor of Science: Nursing
Carleen Health Institute - Florida,

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Resume Overview

School Attended

  • Carleen Health Institute

Job Titles Held:

  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate I
  • Clinical Research Data Coordinator


  • Bachelor of Science

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