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Lead Clinical Monitoring Specialist

hace 2 meses

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo
Position Overview:

The Senior Clinical Research Associate (Sr CRA) plays a pivotal role in overseeing and coordinating the clinical monitoring and site management processes. This position is essential in ensuring compliance with ICH GCP, FDA regulations, local laws, and internal standard operating procedures.

Key Responsibilities:
  • Conducts thorough site visits to evaluate adherence to protocols and regulatory standards, ensuring all necessary documentation is maintained.
  • Engages in ongoing communication with investigative sites to verify that protocols are being followed and any identified issues are addressed promptly.
  • Monitors investigator sites to validate the accuracy of clinical report form entries against patient records.
  • Documents findings and observations in compliance with approved business writing standards, escalating any deficiencies to clinical management with proposed solutions.
  • Provides regular updates on trial status and progress to the Clinical Team Manager, ensuring that study systems are kept current.
  • Participates in investigator meetings and collaborates with client companies to identify and initiate qualified investigative sites.
  • Facilitates effective communication between investigative sites, client companies, and the project team through various channels.
  • Ensures compliance with local regulations and ICH GCP throughout the lifecycle of clinical trials, managing essential documents as required.
  • Completes administrative tasks, including expense reports and timesheets, in a timely manner.
Essential Qualifications:

The ideal candidate will possess a strong background in clinical monitoring, with a minimum of 4 to 5 years of relevant experience. This role requires a proactive approach to problem-solving and the ability to work collaboratively within a team environment.