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Study Coordination Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia IQVIA Argentina A tiempo completo

**Study Coordination Specialist**

We are looking for a highly skilled Study Coordination Specialist to join our team at IQVIA Argentina. As a Study Coordination Specialist, you will play a critical role in overseeing remote site monitoring activities, ensuring compliance with study protocols, regulations, and sponsor requirements.

Key Responsibilities:

  • Manage site management, data review, and query resolution on assigned projects.
  • Conduct study evaluation, initiation, remote monitoring, and close-out visits remotely. May monitor and/or co-monitor at sites when needed.
  • Serve as a primary contact between the business and the investigative site, ensuring proper documentation of site management communications.
  • Collaborate with field CRAs to perform routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
  • Work with field CRAs to resolve and document outstanding site issues/action items.
  • Review the quality and integrity of patient data at assigned sites through the remote review of electronic case report form (CRF) data. Ensure timely transmission of clinical data from assigned study sites and work with sites to resolve data queries.
  • Assist with final data review and query resolution through database lock. Inclusive of patient profile and data listings review.
  • Perform risk-based quality trial management to identify, assess, control, communicate, and review study risk. This data surveillance is performed at specified intervals and throughout the duration of the trial per the study plan.
  • Make recommendations about adjustments to Key Performance Indicators (KPIs) and data analytics reviewed to ensure output continues to be appropriate.
  • Assist with and attend Investigator Meetings on assigned studies.
  • Authorized to request site audits for reasons of validity.
  • May help ensure timely and appropriate site payments and updates to systems as required to ensure proper timing and amount of payments.

Requirements:

  • Bachelor's Degree in scientific discipline or health care preferred.
  • Minimum of 2 years of clinical experience required.
  • Knowledge of clinical research process and medical terminology.
  • Written and verbal communication skills, including good command of English language.
  • Good organizational and problem-solving skills.
  • Ability to manage multiple priorities within various clinical trials.
  • Ability to reason independently to assess and recommend specific solutions in clinical settings.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Ability to understand electronic data capture, including basic data processing functions.
  • Familiarity with current International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and applicable regulations to the conduct of clinical research.