CRA (Freelance)
Lindus HealthFull Time
Mid-level (3 to 4 years)
Candidates should possess a Bachelor's degree in life sciences or a 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 essential. Preferred qualifications include experience with Clinical Trial Management Systems (CTMS) and a strong understanding of German clinical trial regulations.
The Senior Clinical Research Associate will conduct site monitoring responsibilities for clinical trials, providing oversight and leadership to ensure compliance and quality. This includes performing qualification, initiation, interim, and close-out visits, reviewing monitoring reports, ensuring protocol compliance, and verifying data integrity through source document review. The role also involves managing study budgets, facilitating communication between sites and cross-functional departments, assisting with regulatory document collection and contract negotiation, and training/mentoring junior CRAs. Responsibilities extend to ensuring investigational product accountability, maintaining regulatory binders, facilitating adverse event reporting, resolving data discrepancies, and contributing to audit preparation and CTMS development.
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.