Clinical Trials Operations Lead

Astera; East Brunswick Township (NJ); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Paid time off

401(k) plan with company contribution

Profit sharing

Tuition assistance

Employee referral bonus

Job summary

Astera Cancer Care seeks a Manager of Research Operations in New Jersey to oversee the integrity, quality, and compliance of clinical trials. You will supervise coordinators, refine workflows, and monitor visits with sponsors under the Director of Clinical Research and PIs.

Responsibilities include protocol review, subject screening, IP inventory control, data integrity, and audits. Travel to all offices may be required; strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor’s degree in biology, life sciences or equivalent.
• At least 5 years of clinical research experience.
• Previous supervisory experience preferred.

Responsibilities

• Supervise clinical research coordinators, ensuring workload balance and adherence to regulatory and protocol requirements.
• Collaborate cross-functionally to design and refine workflows and SOPs for quality and efficiency in clinical trial operations.
• Manage site qualification, initiation, and close-out visits with study sponsors and support successful trial execution.
• Review new study protocols and consent documents to ensure understanding of objectives, methodology, and safety monitoring.
• Oversee subject screening to ensure eligibility assessments based on medical history and protocol criteria.
• Ensure study visits follow protocol requirements, including procedures and testing.
• Oversee investigational product inventory, accountability, and reconciliation per sponsor and regulatory expectations.
• Ensure accurate data collection and entry into sponsor systems and internal databases.
• Serve as liaison with sponsor monitors and support monitoring visits.
• Lead review and dissemination of protocol amendments and safety notices with staff.
• Support sponsor audits, FDA inspections, and internal quality reviews.
• Maintain confidentiality and patient-centered care at all times.
• Perform other related duties as assigned.

Skills

Supervisory experience

Education

Bachelor’s degree in biology / life sciences

Job description

Astera Cancer Care seeks a Manager of Research Operations in New Jersey to oversee the integrity, quality, and compliance of clinical trials. You will supervise coordinators, refine workflows, and monitor visits with sponsors under the Director of Clinical Research and PIs.

Responsibilities include protocol review, subject screening, IP inventory control, data integrity, and audits. Travel to all offices may be required; strong leadership and regulatory knowledge are essential.