Anna Denisova

Anna Denisova Email and Phone Number

Senior CRA at Premier Research @ Premier
Anna Denisova's Location
Cary, North Carolina, United States, United States
Anna Denisova's Contact Details

Anna Denisova personal email

n/a
About Anna Denisova

Senior Clinical Research Associate with more than 13-years experience in the international Clinical Trials of phases I – IV in Russia and USA within CROs and pharmaceutical companies environment in Oncology, Pulmonology, Rare Disease, Osteoarthritis, Analgesia, Hematology areas in adults and children.Experienced user of different kind of electronic data capture systems, eMR /eReg portals and vendorsExperienced associate in the monitoring of high-recruiting and fast recruiting sitesSuccessful audits in Oncology and Analgesia studies within 2017-2021.Experience in the preparation of the sites to data cut and snapshots of different kind including random cross-check in shorten timelines, individual training programs for the staff involved.Quality Evaluation and Accompany Visits conducting and reporting.Introduction and education courses for junior CRAs.

Anna Denisova's Current Company Details
Premier

Premier

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Senior CRA at Premier Research
Anna Denisova Work Experience Details
  • Premier
    Senior Clinical Research Associate
    Premier Sep 2016 - Present
    Marshalltown, Ia, Us
    • All aspects of clinical monitoring: site qualification, initiation, interim monitoring visits and close-out activities;• Assistance in sites' recruitment, subjects' safety, data quality, project specific plans, ICH/GCP/ISO requirements, and adherence to local regulations;• To be in compliance with managing monitoring metrics, i.e. visits frequency, trip reports and letters submission/finalization, data verification and queries management in timely manner; • Ability to identify monitoring risks, effective escalation the issues identified and assistance in their following resolution;• Tracking of site visits for assigned projects at least 3 months ahead and maintaining CRA calendar;• Expense reports submission of in timely manner and right way and order; • Maintenance of all applicable electronic systems up-to-date: visits schedule, report/letters submission/finalization, Action Items and Protocol Deviations and communication;• Training Compliance: 100% of all SOPs, project specific and Therapeutic training for assigned studies to be completed with the score not less than 80%;• Maintaining of all regulatory documents in current condition their submission/processing in eTMF in timely manner; • Proactively identify site trends and issues in order to prevent potential resourcing conflicts; • Assistance and mentoring team members with less experience
  • Premier Research
    Senior Clinical Research Associate
    Premier Research Jul 2012 - Sep 2016
    Morrisville, Nc, Us
    All aspects of clinical monitoring: site qualification, initiation, interim monitoring visits and close-out activities;• Assistance in sites' recruitment, subjects' safety, data quality, project specific plans, ICH/GCP/ISO requirements, and adherence to local regulations;• To be in compliance with managing monitoring metrics, i.e. visits frequency, trip reports and letters submission/finalization, data verification and queries management in timely manner; • Ability to identify monitoring risks, effective escalation the issues identified and assistance in their following resolution;• Tracking of site visits for assigned projects at least 3 months ahead and maintaining CRA calendar;• Expense reports submission of in timely manner and right way and order; • Maintenance of all applicable electronic systems up-to-date: visits schedule, report/letters submission/finalization, Action Items and Protocol Deviations and communication;• Training Compliance: 100% of all SOPs, project specific and Therapeutic training for assigned studies to be completed with the score not less than 80%;• Maintaining of all regulatory documents in current condition their submission/processing in eTMF in timely manner; • Proactively identify site trends and issues in order to prevent potential resourcing conflicts; • Assistance and mentoring team members with less experience
  • Astrazeneca
    Clinical Research Associate
    Astrazeneca Dec 2011 - Jul 2012
    Cambridge, Cambridgeshire, Gb
    • Collaboration with Russian Regulatory regarding studies submission, getting approvals and extension (if needed);• Assistance to sites in the submission to Local Ethic Committees;• Conducting of Selection, Initiation , Interim Monitoring and Close-out visits;• Trip reports and monitoring letters prep (confirmation and follow up)• Ongoing support of investigating sites, preparation to data cut and snapshot;• Re-monitoring and remote in-house monitoring (where needed) per issues identified; • Assistance in the preparation of Investigators’ meetings and study-related trainings;• Assistance in site Contracts negotiation and further processing;• Assistance in invoices preparation and further processing.
  • Worldwide Clinical Trials
    Cra
    Worldwide Clinical Trials Apr 2008 - Dec 2011
    Research Triangle Park, Nc, Us
    • Collaboration with Russian Health Authorities for study submission, getting approval in time and extension (where needed);• Assistance to sites Regulatory in study package submission to Local Ethic Committees;• Conducting of Selection, Initiation , Interim Monitoring and Close-out visits;• Monitoring reports, confirmation and follow up letters;• Guidelines to Investigators and ongoing support of investigative sites;• Re-monitoring and remote in-house monitoring (where needed) as per issues identified and business needs; • Assistance in the preparation of Investigators’ meetings and study-related training;• Assistance in site Contracts negotiations and further processing;• Assistance in invoices preparation and further processing
  • Ural State Trade University, Trade And Economy Department, Yekaterinburg, Russiaremier Research
    Lecturer, The Secretary Of Faculty Academic Council
    Ural State Trade University, Trade And Economy Department, Yekaterinburg, Russiaremier Research Jan 2003 - Sep 2007
    • Preparation and annual update of the content of full/shortened courses in the field of Organic, Bioorganic and Food Chemistry including the Derivatives of Natural Compounds (assigned for students learning food technology and trade-and-economic subjects);• Preparation and lecturing of the courses above;• Students’ Diploma review;• Research scientific publications preparation and review;• Creation of guidelines, course programs and supporting materials;• Participation in scientific meetings and conferences
  • Ural State Technical University, Chemistry Department, Organic Synthesis Lab
    Chemist Researcher
    Ural State Technical University, Chemistry Department, Organic Synthesis Lab Sep 1990 - Sep 2007

Anna Denisova Skills

Data Analysis On Site And Remote Monitoring Russian Food Chemistry E Communication

Anna Denisova Education Details

  • Post-Graduate Course In Organic Chemistry
    Post-Graduate Course In Organic Chemistry
    Organic Chemistry
  • Ural State Technical University
    Ural State Technical University
    Organic Chemistry

Frequently Asked Questions about Anna Denisova

What company does Anna Denisova work for?

Anna Denisova works for Premier

What is Anna Denisova's role at the current company?

Anna Denisova's current role is Senior CRA at Premier Research.

What is Anna Denisova's email address?

Anna Denisova's email address is an****@****rch.com

What schools did Anna Denisova attend?

Anna Denisova attended Post-Graduate Course In Organic Chemistry, Ural State Technical University.

What skills is Anna Denisova known for?

Anna Denisova has skills like Data Analysis, On Site And Remote Monitoring, Russian, Food Chemistry, E Communication.

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