Clinical Research Associate
Abarca HealthFull Time
Junior (1 to 2 years)
Candidates must have experience as a Clinical Research Associate (CRA) and be proficient in risk-based monitoring, root cause analysis, critical thinking, and problem-solving. Familiarity with data accuracy checks (SDR, SDV, CRF review), investigational product assessment, and business writing standards is necessary. The role requires the ability to escalate issues, maintain communication with investigative sites, and update study systems like CTMS. Experience with site initiation, trial close-out, document management according to ICH-GCP, and participating in investigator meetings is also required.
The Sr CRA will monitor investigator sites using a risk-based approach, identifying process failures and implementing corrective actions to ensure compliance. They will ensure data accuracy through various review methods, assess investigational products, and document observations in timely reports. Responsibilities include escalating deficiencies, managing site communication, updating study systems, participating in investigator payments, and conducting file reviews. The role also involves identifying potential investigators, initiating clinical trial sites, ensuring trial close-out, and maintaining essential study documents. Additionally, the Sr CRA will contribute to project teams, facilitate communication between sites and the project team, respond to regulatory requirements, and complete administrative tasks.
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.