Clinical Research Associate, Sponsor Dedicated, Oncology

About the role

As a Clinical Research Associate, you’ll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.

Responsibilities

• Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
• Evaluate site practices for protocol adherence and escalate quality issues as needed.
• Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
• Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.
• Mentor clinical staff through co-monitoring and training visits.
• Work closely with study team members to support project execution.
• Manage site finances and retrieve invoices as per local requirements.

Qualifications

• BS Degree in a scientific discipline or healthcare preferred.
• Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
• Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
• Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.
• Effective time and financial management, and the ability to build strong working relationships.

Pay

The potential base pay range for this role, when annualized, is $90,200.00 – $197,500.00. The actual base pay offered may vary based on job-related qualifications, location, and/or schedule. Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.