Contract Lead Clinical Research Associate – Oncology / Solid Tumor

Location: Remote / Home-Based
Contract: 12 Months | 1099
Rate: $100-$110 per hour
Hours: Full-Time | 40 Hours per Week

Are you an experienced Lead CRA with a strong oncology background who thrives in a fast-paced biotech environment? This is an exciting opportunity to work directly with an innovative, emerging biotech company through a Functional Service Provider (FSP) model, playing a critical role in the delivery of complex oncology and solid tumor clinical trials.

We are seeking a proactive, hands-on Lead CRA who is comfortable working in a lean, agile environment, taking ownership of clinical monitoring activities, overseeing CRA teams, and managing external vendors. The successful candidate will be highly adaptable, confident managing competing priorities, and experienced in supporting smaller biotech organizations where timelines move quickly and accountability is key.

Key Responsibilities:

• Provide leadership and oversight to CRA teams throughout clinical studies.

• Manage clinical monitoring activities, study timelines, and site performance.

• Oversee external vendors, ensuring quality, accountability, and timely delivery.

• Work closely with biotech stakeholders through an FSP delivery model.

• Ensure compliance with FDA regulations, ICH-GCP, and study protocols.

• Review monitoring reports, clinical data, and TMF/eTMF documentation.

• Identify study risks, resolve operational challenges, and maintain study quality.

Candidate Requirements:

• Recent oncology, solid tumor clinical trial experience - essential.

• Proven experience as a Lead CRA or Senior CRA with significant CRA oversight responsibilities.

• Experience working within an FSP model and/or supporting small to mid-sized biotech organizations.

• Strong vendor management experience and ability to coordinate external stakeholders.

• Comfortable working in a fast-paced, agile environment with changing priorities.

• Strong understanding of FDA regulations, ICH-GCP, and clinical monitoring requirements.

• Excellent communication, leadership, and problem-solving skills.

What's on Offer?

• $100–$110 per hour on a 1099 basis.

• 12-month contract with full-time hours.

• Opportunity to work closely with an innovative biotech organization on complex oncology trials.