Do you have passion for clinical research and would you like to develop your medical knowledge and competencies? Our client is looking for a talented and driven person to fulfil CTA position in Moscow.
The Role and your Responsibilities:
Provide initial support to Site Managers (CRA) by distributing and tracking investigator feasibility questionnaires, tracks and summarizes results.
Upon selection of investigator sites, the CTA will be responsible for the collection and review of regulatory documents for accuracy and completeness at study start up as well as throughout study.
Communicates with sites on document updates and corrections; liaise with Site Managers on trial documents and study site readiness, initiates and tracks confidentiality agreements with sites, contact information, initiates sites in CTMS.
Distributes final documents (investigator list, IB, protocol, ICF template, FDF) to sites.
Updates and ensures accuracy of sites in the database
Reviews documents received from sites for accuracy and completeness. Ensures that they comply with SOP’s and regulations. Confers with the manager regarding changes as appropriate.
Reviews Informed Consent modified by investigator site in conjunction with LTM. Secures approval of changes.
Maintains Trial Master File (IF) either paper or eTMF.
Coordinates central IRB submissions.
Processes, tracks, and distributes documents as required for protocol amendments
What is required:
Education BSN/BS/MS or BA required.
Minimum of 1 year experience in clinical environment as CTA
Excellent written and oral communication skills.
Knowledge of Microsoft Office applications especially Excel.
Ability to collaborate and build strong partnership/relationships with all functions involved in the trial.
For further information about this position contact: Orsolya.Berke@docsglobal.com