Senior Clinical Research Associate

Job Title: Freelance Clinical Research Associate (CRA) – Oncology

Location: Florida, United States (Remote with Regional Travel)

Contract Type: Independent Contractor / Freelance

FTE: 0.7

Therapeutic Area: Oncology

Start Date: Immediate

Travel Requirement: Approximately 50–60% within Florida

Position Overview

We are currently seeking an experienced and highly motivated Freelance Clinical Research Associate (CRA) to support our oncology clinical trials across multiple sites in Florida. This role offers an excellent opportunity for a skilled independent CRA to contribute to the advancement of cancer research while enjoying the flexibility of a contract-based position.

The ideal candidate will have a strong background in monitoring oncology trials, a deep understanding of regulatory and clinical guidelines, and the ability to manage investigative sites with professionalism and autonomy.

Key Responsibilities

• Perform all aspects of site management and monitoring activities in accordance with ICH-GCP, FDA regulations, and study-specific protocols
• Conduct qualification, initiation, routine monitoring, and close-out visits
• Ensure the integrity of clinical data and the protection of study participants by verifying source documentation, case report form (CRF) entries, and regulatory compliance
• Identify, document, and follow up on site issues and protocol deviations, ensuring timely resolution
• Provide ongoing support and training to site staff regarding protocol requirements, study procedures, and data entry standards
• Collaborate with cross-functional teams including project management, clinical operations, and data management to ensure study timelines and deliverables are met
• Prepare and submit accurate and timely monitoring visit reports and related documentation
• Support audit readiness and participate in regulatory inspections as required

Candidate Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipline (advanced degree preferred)
• Minimum of 2 years of independent clinical monitoring experience, including at least 1 year in oncology trials
• Demonstrated knowledge of clinical trial methodologies, ICH-GCP guidelines, and relevant regulatory requirements (FDA, EMA, etc.)
• Experience with electronic data capture (EDC) systems such as Medidata RAVE, Veeva Vault, or similar platforms
• Exceptional communication, organizational, and problem-solving skills
• Ability to work independently with minimal supervision while maintaining high-quality standards
• Willingness and ability to travel throughout Florida
• Valid driver’s license and access to reliable transportation

Preferred Qualifications

• Prior freelance or contract-based CRA experience
• Experience across multiple oncology indications or study phases (Phase I–III)
• Fluency in Spanish is a plus, but not required