CRA (Freelance)
Lindus HealthFull Time
Mid-level (3 to 4 years)
Candidates should possess a BS/BA in a life science or related discipline and have at least 3 years of experience in the pharmaceutical, biotechnology, or CRO industry, with 2 years specifically in clinical monitoring. Experience with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs is necessary. Familiarity with Clinical Trial Management Systems (CTMS) is also required.
The Senior Clinical Research Associate will conduct site monitoring responsibilities, provide oversight and guidance for clinical trials, and ensure compliance and quality. Key duties include reviewing monitoring reports, conducting site visits, coordinating with cross-functional departments, assisting with monitoring plans and training, managing study budgets for stand-alone projects, performing qualification, initiation, interim, and close-out visits, ensuring data integrity through source document review, and facilitating adverse event reporting. The role also involves resolving data queries, identifying and solving site issues, preparing for audits, assisting with CRA training and mentoring, and collaborating on CTMS development and maintenance.
Pharmacy Benefit Management services provider
Abarca Health provides Pharmacy Benefit Management (PBM) services, focusing on flexible and user-friendly solutions for health plans, employers, and government programs like Medicare and Medicaid. Its main product, the Darwin platform, allows clients to quickly implement and modify benefit designs while ensuring compliance with regulations. Abarca Health manages over $5.3 billion in drug spend and processes 100 million prescription claims annually, offering additional services like home delivery for prescriptions. The company's goal is to deliver exceptional service and innovative solutions in the PBM market.