DirecciónThe Regulatory Affairs Associate 2 performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the Study Start Up Associate will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
What you will be doing:
- Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
- Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
- Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
- Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Documents site and Sponsor contact and study interactions in a timely and professional manner.
- Assists with resolution of investigational site/data queries.
- Liaises with project team members regarding study site issues.
- Provides quality review of the informed consent template.
- Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
- Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments.
- Performs other duties as assigned.
You are:
- Bachelor’s degree in Science or Health
- At least 3-4 years of experience responsable for Regulatory Affairs activities in Argentina.
- Experience with PC-Windows, word processing, and electronic spreadsheets required.
- Advanced English
- Have availability to travel at least 2-3 times per week to the offices in the North Zone
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know,
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