Clinical Research Associate; Oncology Monitoring Experience Required
Abarca HealthFull Time
Mid-level (3 to 4 years)
Candidates should possess two or more years of onsite monitoring experience and experience monitoring oncology, along with a strong understanding of ICH-GCP guidelines and applicable regulations. The role requires overnight travel either regionally or nationally, dependent on business needs, and the ability to conduct remote or on-site visits to assess protocol and regulatory compliance.
The Senior CRA I will perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. They will also manage procedures and guidelines from different sponsors and/or monitoring environments, act as a site processes specialist ensuring trial compliance, develop collaborative relationships with investigational sites, conduct monitoring tasks in accordance with the approved monitoring plan, and participate in investigator meetings as necessary. Additionally, the role involves monitoring investigator sites with a risk-based approach, applying RCA and problem-solving skills, ensuring data accuracy, documenting observations, escalating issues, and providing trial status tracking reports to the Clinical Team Manager.
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.