Clinical Research Associate monitoring clinical studies in immunology and cardiovascular diseases at AstraZeneca. Ensuring accurate data submission and reporting in a collaborative team environment.
About the role
- Senior Clinical Research Associate responsible for site management and monitoring for Karius. Ensures compliance with protocols and GCP guidelines during clinical trials.
Responsibilities
- Perform on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
- Conduct source data verification to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documents and the protocol.
- Manage day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.
- Proactively identify and document site level risks and issues, respond to study specific questions, and manage escalations through to resolution.
- Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.
- Collaborate closely with investigators and internal clinical teams to support effective study start up, conduct, and close out and to ensure successful trial execution.
- Oversee the execution of clinical trial activities in accordance with Good Clinical Practices.
Requirements
- Bachelor's degree in a life sciences or health-related field.
- 5+ years of clinical trial experience to include study monitoring; experience with LDTs or in vitro diagnostic devices strongly preferred. 3+ years experience with a master's degree.
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
- Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively.
- Proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.
- CCRA/CCRP certification is desired.
Benefits
- Travel required (up to 80%)
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Research Analyst developing quantitative analyses on the Chinese energy market for clients. Enjoy autonomy and engagement opportunities in a supportive environment.
Research Specialist at Dentons, a global law firm, focusing on AI - enhanced legal research and team collaboration across Canadian offices.
Research Specialist providing legal and business research support at Dentons Canada. Utilizing AI tools and collaborating in a hybrid environment across the firm.
Senior Research Analyst supporting cost and emissions analysis for copper metal mines globally. Joining a diverse team to produce insights for mining industry stakeholders.
Mortgage Loan Research Specialist processing loan data and verifying client accommodations for mortgage services. Ensuring compliance with regulatory and investor guidelines in a fast - paced environment.
Senior Operations Research Analyst providing financial management and operational analysis for Air Force budget. Supporting the AFSC with specialized research and analytical investigations.
Clinical Research Associate ensuring sites comply with clinical study protocols at IQVIA. Performing monitoring visits and managing study progress across various locations.
Research Analyst at First Momentum Ventures exploring investment opportunities in physical & computational biology. Collaborate with a technical team while building impactful networks and research.
GIS Research Associate at the Center for Urban Transportation Research contributing to transit planning and compliance. Integrating demographic data with transit datasets to ensure planning and regulatory requirements are met.