Study Support Associate

hace 2 semanas

Ciudad de México, Ciudad de México Icon Plc A tiempo completo

About ICON Plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Summary

We are seeking a highly motivated and detail-oriented Study Support Associate to join our team. As a Study Support Associate, you will play a critical role in supporting the study team and ensuring the successful execution of clinical trials.

Key Responsibilities

  • Recognize, exemplify and adhere to ICON's values, which center on our commitment to People, Clients and Performance
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  • Provide general administrative support to the team
  • Support the Study Start Up Leads including tracking, filing and other coordinating tasks
  • Assist the team with submission documentation and guidelines, as appropriate
  • Collate and verify, for completeness, submission documentation for submission to the Regulatory/Competent Authority (CA)/Ethics Committee (EC) and other relevant authorities
  • Coordinate, dispatch and track submissions to CNEC and other relevant authorities
  • Assist with site contracting process, as needed
  • Assist with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements
  • Assist with SAS/Steering Committee organization and attendance when applicable
  • Demonstrate increasing ability to manage site assignments and workload
  • Maintain Sponsor and patient confidentiality
  • Actively participate in regular meetings with Project Managers or delegate, and/or RS Lead to discuss project strengths and challenges associated with recruitment, enrolment, site communications and site responsiveness
  • Assume additional responsibilities as detailed and documented by PM or delegate, RS Lead or Line Management
  • Assist in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines
  • Demonstrate ability to implement the study monitoring plans/metrics as appropriate and agreed upon
  • Working knowledge of and compliance with local regulatory requirements
  • Compliant and current with departmental and corporate policies and procedures

Requirements

  • Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, proactive interaction with study team and site staff
  • Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects others point of view and seeks advice when appropriate
  • Supports and fosters relationships with internal and external customers
  • May support the development of proposals for new business and attend bid defence presentations
  • May attend bid defence presentations, as needed
  • Supports internal and external capabilities presentations
  • Participates in training and mentoring of junior staff
  • Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budget
  • Supports and follows departmental policies and procedures
  • Takes responsibility for project tasks and sees these tasks through to successful completion
  • Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives
  • Maintains professional interpersonal relationships with team, sites, and Sponsor
  • Continues to increase knowledge of therapeutic areas, GCP and any applicable local regulatory requirements

Working Conditions

This role will require approximately 25% travel, including driving and flying.

Language

The primary language for this role is English.

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