Arrowhead Pharmaceuticals is seeking to solve the business problem of developing medicines that treat intractable diseases by silencing the genes that cause them. The Sr. Clinical Research Associate will support the planning, execution, and management of clinical studies to bring these innovative drugs to patients.
Requirements
- 5 years in clinical research and development
- 3 years onsite monitoring/site management experience
- Experience managing/supervising vendors
- Highly proficient knowledge and understanding of ICH-GCP
- 4-year college degree
- CRA certification
Responsibilities
- Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
- Routinely monitor TMF inspection readiness for assigned studies
- Assist Study Lead with investigational product and ancillary supplies management, accountability and reconciliation activities
- Collect and/or review Essential Documents from investigational sites
- Review monitoring visit reports for accuracy and completeness
- Perform QC (formatting, spelling and grammar, accuracy, consistency) of study-level documents (master ICFs, study plans, manuals, CRFs/CRF completion instructions, etc.) in alignment with study protocols
- Support central/referral laboratory set-up and on-time activation (eg specifications, user manual) as delegated by the Study Lead
Other
- All applicants must have authorization to work in the US for a company.
