Job Title: Sr. CRA Contractor (Oncology)

Work Location: Texas

Summary:

Seeking an experienced Sr. Clinical Research Associate (CRA) Contractor to support a Phase I Leukemia study. This contract role involves a mix of remote and on-site monitoring, covering two sites in Texas. The position requires strong expertise in hematology/oncology clinical trials, particularly with leukemia, and the ability to work independently with minimal supervision.

Responsibilities:

• Oversee and track study monitoring activities, including both remote and on-site visits, ensuring compliance with study protocols and regulatory requirements.
• Develop and maintain essential study documents such as protocols, informed consent forms, case report forms, and study manuals in collaboration with project leads.
• Manage clinical study sites, addressing site performance issues related to protocol adherence, GCP/ICH compliance, subject recruitment, and data management.
• Conduct site qualification, initiation, routine monitoring, and close-out visits, providing clear documentation and timely follow-up communications.
• Perform remote monitoring to identify trends or issues, and ensure timely resolution of data queries and site monitoring findings.
• Maintain and reconcile clinical study files, ensuring all documentation is accurate, complete, and uploaded within required timelines.
• Support site management activities, including site training, patient status tracking, and investigator grant reconciliations, while assisting with safety case management as needed.
• Provide regular updates to project management, participate in meetings, mentor junior team members, and assist with quality control of study reports and safety narratives.

Qualifications:

• Minimum of a bachelor’s degree in a scientific discipline; BA or RN with relevant experience also considered.
• At least 5 years of experience in the pharmaceutical or biotechnology industry.
• Minimum of 5 years of CRA/clinical study monitoring experience.
• Direct experience with leukemia clinical trials is required.
• Experience monitoring Phase I trials, especially using BOIN design, and familiarity with European LeukemiaNet 2022 AML response criteria is highly desirable.
• Proficiency with Medidata RAVE EDC preferred; experience with Medidata CTMS and eTMF (RCM) is a plus.
• Ability to travel 1-2 days per month for on-site visits as needed.
• Strong written and oral communication, organizational skills, attention to detail, and ability to work independently with limited supervision.
• Solid understanding of clinical trial processes, federal regulatory requirements, and GCP guidelines.
• Experience mentoring junior CRAs or conducting GCP audits is a plus.
• Proficiency with Microsoft Office and standard PC applications.

Published Category: Clinical Operations & Development