CRA (Oncology) Sponsor side!

This is a remote or hybrid position with a small, clinical-stage biotech focused on developing novel medicines for cancer.

About us

We are a financially stable, late-phase biotech company with a strong pipeline and opportunities for growth. We offer a flexible schedule.

Responsibilities

• Assist with the oversight of the design, implementation, and management of clinical trials from inception to completion.
• Ensure clinical sites are compliant with the study protocol, FDA regulations, and other applicable regulatory requirements.
• Conduct site visits to assess trial progress, verify data accuracy, and resolve issues.
• Collaborate with investigators and clinical staff to protect participant safety and rights.
• Prepare and review study-related documents such as protocols, informed consent forms, and case report forms.
• Coordinate with the data management team to ensure accurate and reliable data collection.
• Participate in the preparation and presentation of clinical trial results to internal teams, regulatory agencies, and other stakeholders.

Requirements

• A bachelor's degree in a life science, nursing, or a related field. An advanced degree is preferred.
• A minimum of 3-5 years of Oncology experience as a Clinical Research Associate in the biotech/pharma space.
• Proven experience in managing or co-managing clinical trials, including different phases of clinical research.
• A thorough understanding of FDA regulations and guidelines related to clinical research.
• Strong organizational skills with the ability to manage multiple tasks and meet deadlines.
• Excellent communication and interpersonal skills.
• Proficiency in using clinical trial management systems and related software.
• Experience with solid tumors is required.

Pay

$125,000 - $140,000 per year