Senior Clinical Research Associate, ECD, St. Petersburg

Job Location(s) RU-St. Petersburg
Job Number
Job Category
Clinical Research Associate
Position Type

Job Overview

Duties and Responsibilities:

  • Meets all requirements of the applicable preceding Clinical Research Associate level
  • May participate in identification/feasibility and recruitment of investigator sites, collection of investigator documentation, pre-study visits and site management responsibilities.
  • Creates site reference manuals and other site training materials
  • Generates study specific monitoring plans
  • May serves as the Primary contact for the sponsor/clinical sites
  • Organizes and delivers presentations at Sponsor and Investigator/Initiation Meetings.
  • Assures implementation of Project Plans related to the Clinical Monitoring responsibilities
  • May assist in Bid Defenses and Business Development including proposal generation and feasibility tasks.
  • May participate in the development of protocols and Case Report Forms
  • Develops contingency plans and alternate strategies
  • General on-site Monitoring Responsibilities:
  • Ensures that study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements, as written.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
  • Ensures that the Site Regulatory Documents are complete and current throughout the duration of the trial.
  • Ensures that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
  • Ensures the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
  • Prepares accurate and timely trip reports.
  • Identification and follow up of SAEs at study site for which he/she is responsible
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems.
  • May serves as Project Manager for small-mid sized studies
  • May manage/assist with complex clinical projects and lead project teams
  • May serves as lead CRA for a protocol or project.
  • Responsible for coordinating initial and on-going protocol, CRF and monitor training.
  • specifics, ensures consistency at study sites and leverages best practices. Responsible for overseeing CRA performance, reviewing trip reports for content and timeliness.
  • Tracks progress of projects and initiates appropriate actions to achieve target objectives.
  • Oversees the development of the conventions for CRF transcription
  • Co-manages fiscal responsibilities (e.g. fiscal responsibility for tracking the monitoring expenses against the project budget)
  • May be responsible for the coordination of vendor activities, including translation of study documents
  • Interacts with internal work groups to evaluate needs, resources and timelines

Education / Qualifications

University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).



  • Thorough knowledge of ICH guidelines, GCP and the clinical trial process
  • Thorough knowledge of the drug development process
  • Demonstrated ability to independently manage complex clinical projects
  • Experienced in leading project teams
  • Project Coordination and/or project management experience preferred
  • Excellent verbal and written communication skills in both local and English languages
  • Advanced computer skills with good working knowledge of a range of computer packages including Electronic CRF processes
  • Basic understanding of statistical programming, data management, and clinical trial report preparation processes
  • Valid Drivers License


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