Clinical Research Associate (CRA)

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits while ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Partner with study sites to develop, implement, and track recruitment plans to meet enrollment and project goals.
• Provide protocol training and maintain consistent communication with site personnel to manage expectations and resolve issues.
• Evaluate site practices for protocol adherence and identify, document, and escalate quality or compliance concerns as needed.
• Track regulatory submissions, patient recruitment, enrollment activities, data collection, and study progress to ensure milestones are achieved.
• Maintain Trial Master File (TMF) and Investigator Site File (ISF) documentation in accordance with regulatory and sponsor requirements.
• Support the development of clinical staff through co-monitoring activities, training visits, and mentorship.
• Collaborate with cross-functional study team members to support overall project execution and successful study outcomes.
• Manage site finances and assist with invoice retrieval and processing in accordance with local requirements.

Qualifications

• Bachelor’s degree in a scientific discipline, healthcare, or a related field preferred.
• Minimum of three (3) years of on-site monitoring experience in oncology clinical trials.
• Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Experience supporting oncology protocols and clinical research studies.
• Proficiency with Microsoft Office applications.
• Excellent written and verbal communication skills.
• Strong organizational, problem-solving, and time-management abilities.
• Demonstrated ability to build and maintain strong working relationships with investigators, site personnel, and study teams.
• Effective financial management skills and experience managing site-related budgets and expenses.

Pay

$100,000-$130,000 salary based on experience, education, and qualifications.

Schedule

Remote work position.