Manager, Research Operations

Astera•East Brunswick, NJ

1d•$120,000 - $130,000•Onsite

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 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 compliant, high-quality trial operations across sites. It works with sponsors, monitors, staff, and cross-functional partners to establish effective workflows, oversee study activities, and support audits, inspections, and quality reviews. The position is based in an office and requires travel to all offices as necessary.

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, including 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 address 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 study data collection, documentation, and entry into sponsor systems and internal databases, consistent with protocol, regulatory, and institutional standards.
Liaise with sponsor representatives and monitors, respond to protocol inquiries, and support monitoring visits, including helping direct reports prepare for and complete monitor visits.
Lead review and dissemination of protocol amendments, safety notices, suspensions, and terminations with direct reports.
Serve as a subject matter expert and resource for staff on investigational product administration, safety profiles, and trial protocols.
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.