Senior Clinical Research Associate

1 week ago


New York, New York, United States ICON Strategic Solutions Full time
Job Summary

ICON Strategic Solutions is seeking a highly skilled Senior Clinical Research Associate - Oncology to join our team. As a Senior CRA, you will be responsible for ensuring the integrity of clinical data and ensuring that studies are conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.

Key Responsibilities
  • Monitoring Activities: Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.
  • Participant Protection: Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
  • Data Integrity: Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
  • Site Management: Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
  • Investigational Product Management: Verifies proper management and accountability of Investigational Product (IP).
  • Reporting: 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.
  • Document Management: 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.
  • Risk Management: Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
  • Audit Preparation: Participates in audit preparation and follow-up activities as needed.
  • Monitoring Visit Types: Independently performs a variety of onsite and offsite monitoring visit types.
  • Site Evaluation: Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
  • Ad Hoc Assignments: Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
  • Training and Development: May serve as preceptor, providing training to less experienced clinical team members.
Requirements
  • 2-3 years of Oncology monitoring experience
  • Strong knowledge of ICH-GCP guidelines, applicable regulations, SOPs, and study processes
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
  • Strong analytical and problem-solving skills
  • Ability to travel up to 80% of the time


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