Job Description

Job Title: Clinical Research Associate (CRA) II/Senior CRA

Job Type: Permanent Full Time

Location: United States - All States

Must Have: Minimum 2 Years of On Site Monitoring Experience & 1 Year of Oncology Experience

Our client is a global leader in healthcare data, technology, and advanced analytics, dedicated to supporting the pharmaceutical and biotechnology industries in the development of ground-breaking treatments. With a strong focus on oncology, our mission is to accelerate the discovery and development of life-changing therapies. They are seeking a highly skilled Clinical Research Associate II (CRA II) to join our team and contribute to the success of cutting-edge oncology clinical trials.

Key Responsibilities:

• Oversee and manage the progress of clinical trials at investigational sites, ensuring adherence to the study protocol, ICH-GCP, and local regulatory requirements.
• Conduct site initiation, monitoring, and close-out visits, offering continuous support to ensure optimal site performance.
• Establish and maintain strong working relationships with investigators, site staff, and other key stakeholders.
• Ensure accurate and timely collection and reporting of clinical trial data.
• Proactively identify potential risks and work with the study team to resolve issues affecting timelines, data quality, or compliance.
• Provide guidance to junior CRAs and assist in their professional development.
• Ensure all clinical trial documentation is maintained in compliance with regulatory requirements and company SOPs.
• Regional travel.

Qualifications:

• A minimum of 2 years of experience as a Clinical Research Associate (CRA) in a clinical research environment.
• At least 1 year of experience in oncology clinical trials, with a solid understanding of oncology treatment modalities and protocols.
• In-depth knowledge of ICH-GCP, FDA, and other regulatory standards and guidelines.
• Excellent organizational, communication, and problem-solving skills.
• Ability to travel to clinical sites as required by the study.
• A bachelor’s degree in Life Sciences or a related field (or equivalent experience).
• CRA certification (e.g., ACRP or SOCRA) preferred but not required.

If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732

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