パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Clinical Research Associate - US - West Coast - FSP
応募 求人ID R0000046413 ロケーション アメリカ合衆国 仕事内容The Clinical Research Associate (CRA) will be a member of the client’s Monitoring team and provide monitoring expertise to individual clinical trials and/or programs.
Key Accountabilities
Oversight of activities
- Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocols
- Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks.
- Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders
- Provide Monitoring expertise, mentoring and training to less experienced team members as required
- Build positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration)
- Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategies
- Provide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as required
- Use regional knowledge to localize study processes and documents where possible
- Represent Monitoring at Investigator Meetings as required
- Perform other tasks as required
Collaborative relationships
- Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.
Skills:
- Ability to travel domestically
- Demonstrates ability to work independently and in a team environment
- Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)
- Excellent oral and written communication skills and strong organizational abilities
Knowledge and Experience:
- Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
- Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
- Experience in Oncology preferred
- 5+ years of relevant monitoring experience
Education:
- BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
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