CRA (Freelance)
Lindus HealthFull Time
Mid-level (3 to 4 years)
Candidates must possess a Bachelor's degree in a life science field. Experience in clinical monitoring and site management, including audit readiness, is required. Familiarity with ICH-GCP guidelines and applicable regulations is essential. Experience with risk-based monitoring, root cause analysis, and critical thinking is also necessary.
The Senior Clinical Research Associate will perform and coordinate clinical monitoring and site management, ensuring audit readiness. Responsibilities include conducting remote or on-site visits to assess compliance, managing documentation, and reviewing data for accuracy. They will assess investigational products, document observations, and report deficiencies to management. The role involves maintaining contact with investigative sites, participating in investigator meetings, initiating clinical trial sites, and performing trial close-outs. Additionally, they will ensure essential documents are complete, provide study status updates, and facilitate communication between sites, clients, and internal teams.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.