Clinical Research Associate
Abarca HealthFull Time
Junior (1 to 2 years)
Candidates must possess a university degree or equivalent experience in a science-related field. A minimum of 2 years of experience in interventional studies is required, along with a proven understanding of ICH-GCP, EU, and FDA requirements. Proficiency in English, strong clinical monitoring skills, and demonstrated knowledge of medical terminology and therapeutic areas are essential. The role also requires well-developed critical thinking, good oral and written communication skills, attention to detail, and the ability to work independently or as part of a team. Solid computer skills, including Microsoft Office proficiency, are necessary.
The CRA will apply root cause analysis, critical thinking, and problem-solving skills to identify and address site process failures, ensuring compliance and reducing risks. Responsibilities include ensuring data accuracy through SDR, SDV, and CRF review via remote and on-site monitoring, and assessing investigational product through physical inventory and records review. The CRA will detail observations in reports and letters according to timelines, advance deficiencies to clinical management, and follow issues through to resolution. They will also participate in the investigator payment process, collaborate with team members on issue resolution, and attend investigator meetings as needed. Initiating clinical trial sites in compliance with protocols, regulations, and ICH-GCP obligations, and ensuring essential documents are complete according to ICH-GCP and applicable regulations are 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.