Clinical Monitor

4 weeks ago


Pittsburgh, Pennsylvania, United States ICON Strategic Solutions Full time
Job Summary

We are seeking a highly skilled Clinical Monitor to join our team at ICON Strategic Solutions. The successful candidate will be responsible for monitoring clinical trials in the field of ophthalmology medical devices.

Key Responsibilities:

  • Conduct onsite and remote monitoring activities in accordance with ICH-GCP guidelines and applicable regulations.
  • Verify the protection of study participants by confirming informed consent procedures and protocol adherence.
  • Ensure the integrity of clinical data and compliance with the approved protocol, GCP, and applicable regulations.
  • Manage investigative site staff to facilitate trial deliverables, including subject enrollment and data delivery.
  • Verify proper management and accountability of Investigational Product (IP).
  • Write and submit reports of investigational site findings and update tracking systems as necessary.
  • Perform key risk assessment and management responsibilities throughout the project.
  • Participate in audit preparation and follow-up activities as needed.
  • Independently perform onsite and offsite monitoring visit types.

Requirements:

  • 2 years of experience supporting clinical trials, including 2 years of onsite 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, as well as presentation skills.
  • Strong interpersonal, collaboration, and time management skills.
  • High proficiency with Microsoft Office and company collaboration applications.
  • 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 and maintain high attention to accuracy.
  • Ability to travel extensively.
  • Ability to establish and maintain effective working relationships with investigative site staff.
  • Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution, or health care professional licensure.

Why ICON?

We offer a comprehensive and competitive total reward package, including a wide range of variable pay and recognition programs, best-in-class employee benefits, supportive policies, and wellbeing initiatives tailored to support you and your family at all stages of your career.

We are committed to developing our employees in a continuous learning culture, where every experience adds to your professional development.

ICON is an equal opportunity and inclusive employer, 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.


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