Clinical Research Associate
Abarca HealthFull Time
Junior (1 to 2 years)
Candidates must have experience monitoring investigator sites using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills. They should be proficient in data accuracy through SDR, SDV, and CRF review, as well as assessing investigational products. Experience in documenting observations, escalating deficiencies, and maintaining communication with investigative sites is necessary. The role requires knowledge of ICH GCP and applicable regulations for clinical trial initiation, site close-out, and essential document management. Collaboration with project teams and clients, along with administrative task completion, is also expected.
The FSP Sr CRA I will monitor investigator sites to ensure compliance and decrease risks, ensuring data accuracy through various review methods. Responsibilities include assessing investigational products, documenting observations, escalating issues, and following up on resolutions. The role involves maintaining contact with sites, conducting monitoring tasks per the plan, participating in investigator payments, and ensuring study systems are updated. Additionally, the position requires identifying potential investigators, initiating clinical trial sites, managing trial close-out, and ensuring essential documents are complete. Facilitating communication between sites, clients, and project teams, responding to regulatory requirements, and contributing to project work and process improvement are also key duties.
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.