Director Clinical Operations Director of Clinical Operations (Phase I /Early Phase Clinical Research)

🚀 Director of Clinical Operations (Phase I / Early Phase Clinical Research)

📍 Miami, FL | On-site

🗓 Full-Time

🌱 Help Advance Life-Saving Clinical Research

Are you passionate about Clinical Operations, Phase I clinical research, regulatory compliance, and leadership? We’re looking for a Director of Clinical Operations (Phase I / Early Phase Clinical Research) to join a growing clinical research organization supporting innovative research programs across multiple therapeutic areas.

If you thrive in a fast-paced clinical research environment and enjoy leading teams, overseeing study execution, and ensuring compliance with FDA, ICH, and GCP guidelines, this could be your next opportunity.

🔬 What You'll Do

✔ Lead and mentor the Clinical Operations team to promote a collaborative and efficient environment

✔ Ensure protocol compliance and maintain high-quality standards across all studies

✔ Collaborate with Principal Investigators and Site Directors to assign studies and develop enrollment strategies

✔ Oversee staff recruitment, training, performance evaluations, and professional development

✔ Monitor protocol adherence and manage the reporting of study deviations

✔ Coordinate study assignments and support clinical research teams throughout study execution

✔ Review study components prior to initiation and identify areas requiring clarification

✔ Oversee study start-up, enrollment activities, and study close-out procedures

✔ Support cross-functional collaboration with sponsors, investigators, and site leadership

✔ Ensure compliance with FDA regulations, ICH guidelines, GCP standards, and company SOPs.

✅ What We're Looking For

🎓 Bachelor's degree in a scientific or healthcare-related field

🧪 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role

🧫 Hands-on experience or exposure with:

• Clinical Operations

• Clinical Research

• Phase I Clinical Trials

• Early Phase Clinical Research

• FDA Regulations

• ICH Guidelines

• Good Clinical Practice (GCP)

• Study Start-Up

• Patient Recruitment

• Site Selection

• Clinical Monitoring

• Data Management

• Study Close-Out

• Team Leadership

• Staff Development

• Protocol Compliance

• Clinical Trial Management

Bonus

• Phase I or Early Phase Clinical Research experience preferred

• Bilingual English and Spanish preferred

💰 Compensation Range

$155,000 - $180,000 annually (depending on experience and qualifications)

Comprehensive Benefits

Health Insurance

Dental & Vision Insurance

401(k) Matching

Paid Time Off

Career Growth Opportunities

📍 Please Note

✅ On-site in Miami, FL

✈️ Travel may be required as needed to support study and operational activities

✅ Relocation assistance discussion available for qualified non-local candidates

🇺🇸 Applicants must be authorized to work in the U.S.

If this sounds like you—or someone in your network—I’d love to connect!

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