Thermo fisher scientific

Overview

Perform and coordinate all aspects of the clinical monitoring and site management process. Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.

About Thermo fisher scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, helping our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver therapeutics to market and increase laboratory productivity.

Requirements & Eligibility

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.

Key Responsibilities

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.