Clinical Research Associate

hace 4 días

Ciudad de México, Ciudad de México Icon Plc A tiempo completo
Job Title: Clinical Research Associate

As a Clinical Research Associate at ICON Plc, you will be part of a dynamic team that is dedicated to delivering high-quality clinical research services to our clients. We are seeking a highly motivated and experienced individual to join our team as a Clinical Research Associate.

Job Summary:

The Clinical Research Associate will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.

Key Responsibilities:
  • Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
  • Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
  • Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
  • Verifies proper management and accountability of Investigational Product (IP).
  • Writes and submits reports of investigational site findings and updates applicable tracking systems.
  • Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
  • Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries.
  • Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
  • Participates in audit preparation and follow-up activities as needed.
  • Independently performs a limited range of onsite and offsite monitoring visit types.
  • Gathers and reviews information for assigned sites and identifies inconsistencies. With guidance from project and functional management, assesses risk and escalates as appropriate.
Requirements:
  • 1 year of experience supporting clinical trials including on-site monitoring experience.
  • In-depth knowledge of the drug development process.
  • In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
  • Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents.
  • Good spoken and written communication skills; good presentation skills.
  • Strong interpersonal, collaboration and time management skills.
  • Excellent skill in the utilization of applicable clinical systems.
  • Excellent critical thinking skills.
  • Excellent organizational skills.
  • Ability to focus on detail for extended periods of time; high attention to accuracy.
  • Ability to travel extensively.
  • Ability to establish and maintain effective working relationships with investigative sites.
What ICON Plc Can Offer:

At ICON Plc, we are committed to delivering high-quality clinical research services to our clients. We offer a competitive salary and a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced individual who is passionate about delivering high-quality clinical research services, we encourage you to apply for this exciting opportunity.

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