Manager, Research Operations

Astera Cancer Care • East Brunswick, NJ

6d

About The Position

This full-time position is responsible for ensuring the integrity, quality, and compliance of clinical trials conducted at Astera Cancer Care. The Manager of Research Operations oversees the accurate execution of study visit procedures and the proper collection and documentation of patient data in accordance with study protocols. A key focus of the role is protecting the health, safety, and welfare of research participants. The position operates under the general supervision of the Director of Clinical Research and Principal Investigators.

The role supervises clinical research coordinators and supports clinical trial operations through cross-functional workflow development, sponsor coordination, study oversight, data quality, and regulatory compliance. The manager also serves as a resource for staff and supports sponsor audits, FDA inspections, and internal quality reviews.

Requirements

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

Nice To Haves

• Previous supervisory experience.

Responsibilities

• Supervise clinical research coordinators, ensuring efficient workload distribution, performance optimization, and adherence to regulatory and protocol-specific requirements.
• Collaborate cross-functionally to design, implement, and refine workflows, processes, and standard operating procedures that support quality and efficiency in clinical trial operations.
• Manage site qualification, initiation, and close-out visits with study sponsors.
• Review new study protocols and informed consent documents with staff to ensure understanding of study objectives, methodology, visit schedules, adverse event reporting, and safety monitoring.
• Oversee subject screening conducted by coordinators and ensure eligibility assessments are based on medical history, current health status, and protocol-specific inclusion and exclusion criteria.
• Ensure study-related patient visits comply with protocol requirements, including clinical procedures, assessments, and testing.
• Supervise investigational product inventory, accountability, and reconciliation across sites in accordance with sponsor and regulatory expectations.
• Ensure accurate, timely, and complete data collection, documentation, and entry into sponsor systems and internal databases, meeting protocol, regulatory, and institutional standards.
• Serve as a liaison with sponsor representatives and monitors, address protocol inquiries, and support monitoring visits.
• Lead review and dissemination of protocol amendments, safety notices, suspensions, and terminations with direct reports.
• Assist direct reports in preparing for and completing monitor visits.
• Act as a subject matter expert and resource for staff regarding investigational product administration, safety profiles, and trial protocol specifics.
• Conduct feasibility assessments and assist with patient screening for enrollment as needed.
• Support sponsor audits, FDA inspections, and internal quality reviews through preparation and participation.
• Uphold professionalism, confidentiality, and patient-centered care.
• Perform other related duties as assigned to support departmental goals.

Benefits

• Medical, dental, vision, life, and disability benefits, with immediate eligibility.
• Health Savings Account (HSA), Flexible Spending Account (FSA), and other ancillary benefits.
• 401(k) plan with company contribution.
• Profit sharing.
• Tuition assistance.
• Employee referral bonus.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager