Hybrid In-House Oncology CRA: Trial Oversight

Coalition of Cancer Cooperative Groups; Philadelphia (Philadelphia County); Hybrid; USD 72,000 - 110,000; Full time

Job summary

Coalition of Cancer Cooperative Groups is seeking an experienced In-House Clinical Research Associate (IHCRA) to coordinate and oversee oncology clinical trials in a hybrid work setting. You will work with the Senior Director, Clinical Trial Managers, Project Managers, and other CRAs to ensure adherence to GCP, SOPs, and FDA regulations.

Advanced opportunities may be available for candidates with prior site monitoring experience and the ability to review and evaluate monitoring trip reports.

Qualifications

• Minimum of three (3) years of oncology clinical research experience.
• Experience as a CRA/monitor/auditor or similar role in oncology.
• Strong organizational, communication and documentation skills.

Responsibilities

• Collaborate with investigators, site personnel, IRB staff and sponsor/funder representatives to support study management.
• Conduct pre-study activities, remote SIVs, site closeout visits and other monitoring activities.
• Assist with site identification and feasibility activities and provide recommendations to project leadership.
• Prepare site regulatory packet templates and coordinate regulatory documentation review.
• Generate and review database reports to identify missing or incomplete EDC data and follow up with monitors.
• Maintain site tracking reports, site contact logs, and study documentation reports.

Skills

Organizational skills

Communication skills

Documentation skills

Collaborative work

Education

Bachelor's degree

Job description

Coalition of Cancer Cooperative Groups is seeking an experienced In-House Clinical Research Associate (IHCRA) to coordinate and oversee oncology clinical trials in a hybrid work setting. You will work with the Senior Director, Clinical Trial Managers, Project Managers, and other CRAs to ensure adherence to GCP, SOPs, and FDA regulations.

Advanced opportunities may be available for candidates with prior site monitoring experience and the ability to review and evaluate monitoring trip reports.