Senior Clinical Research Associate

hace 3 semanas


Xico, México Icon Plc A tiempo completo

At ICON, we pride ourselves on being a leader in the clinical research industry. Our team of experts is dedicated to advancing and improving patients' lives through clinical trials.

Key Responsibilities:

We are seeking a Senior Clinical Research Associate to join our team, who will be responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs, and all applicable rules and regulations.

The Role Responsibilities:

  • Recognize, exemplify, and adhere to ICON's values which center around 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.
  • Serves as the primary contact for sites and investigators participating in studies.
  • Acts as a resource for internal study teams and other ICON departments
  • Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others), and other site management documents.
  • Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan.
  • Participates in QA audits as needed.
  • Regularly attends and contributes to project-specific and departmental meetings
  • Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time.
  • Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs.
  • Maintains and archives study documentation and correspondence, as needed.
  • Assists with site contracting process, as needed.
  • Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
  • With support, demonstrates the ability to manage site assignments and workload
  • Maintains Sponsor and patient confidentiality.
  • Actively participates in regular meetings with Project Managers or delegates, and/or RS
  • LEAD
  • Assists in the development of site and patient enrolment strategies with the project team; works to motivate sites to meet enrolment timelines.
  • Developing 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, and proactive interaction with the study team and site staff.
  • Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects other's point of view, and seeks advice when appropriate.
  • Supports the formation of relationships with internal and external customers
  • May attend bid defense presentations, as needed.
  • Supports internal and external capabilities presentations.
  • Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets.
  • Follows departmental policies and procedures.
  • Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
  • Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives.
  • Maintains professional interpersonal relationships with team, sites, and Sponsor.
  • Increases knowledge of therapeutic areas, GCP, and any applicable local regulatory requirements.
  • Seeks opportunities to demonstrate leadership and enhance own professional growth.
  • Actively participates in Lunch and Learns, Journal Clubs, or other internal company training sessions.


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