Clinical Development Lead, Transplant Expansion / New Indications
BiogenFull Time
Senior (5 to 8 years)
California, United States
Candidates must be experienced Clinical Research Associates (CRA II, Sr CRA, Principal CRA) with expertise in Renal, Transplant, and/or Nephrology. The role requires the ability to perform and coordinate all aspects of clinical monitoring and site management, including remote and on-site visits. Proficiency in risk-based monitoring, root cause analysis, critical thinking, and problem-solving is essential. Experience with data accuracy checks (SDR, SDV, CRF review), investigational product assessment, and timely documentation of observations is necessary. The role also requires maintaining communication with investigative sites, clients, and project teams, and ensuring compliance with ICH-GCP and applicable regulations. Familiarity with clinical trial management systems and participation in investigator meetings and payment processes are also required.
The Clinical Research Associate will perform and coordinate clinical monitoring and site management, including remote and on-site visits, to assess protocol and regulatory compliance. They will ensure data accuracy through various review processes and assess investigational products. Responsibilities include documenting observations, escalating deficiencies, maintaining contact with investigative sites, and conducting monitoring tasks according to the approved plan. The CRA will also participate in the investigator payment process, collaborate on issue resolution, and identify potential investigators. They will initiate clinical trial sites, perform trial close-out activities, and ensure essential documents are complete and compliant with regulations. The role involves tracking study progress, updating study systems, and facilitating communication between sites, clients, and the project team, while also responding to regulatory requirements and audits.
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.