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Senior Clinical Research Associate

2 months ago

Reston, Virginia, United States ICON Strategic Solutions Full time

Job Summary:

At ICON Strategic Solutions, we are seeking a highly experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you 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), ICH-GCP, and all applicable regulatory requirements.

Key Responsibilities:

  • Monitor Oncology and Multi-Therapeutic studies to ensure compliance with regulatory requirements and study protocols.
  • Conduct site initiation visits, interim visits, and close-out visits to ensure that sites are adequately prepared and equipped to conduct the study.
  • Review and verify site documentation, including informed consent forms, case report forms, and other relevant documents.
  • Identify and report any deviations or issues related to the study protocol or regulatory requirements.
  • Collaborate with cross-functional teams, including study managers, data managers, and biostatisticians, to ensure seamless execution of clinical trials.

Requirements:

  • At least 1.5 years of independent monitoring experience in clinical research.
  • Strong knowledge of ICH-GCP, regulatory requirements, and study protocols.
  • Excellent communication and interpersonal skills, with the ability to work effectively with site personnel, study teams, and other stakeholders.
  • Ability to work independently and as part of a team, with a strong attention to detail and organizational skills.