Astera Cancer Care · 1 week ago
Manager, Research Operations
East Brunswick, NJ
Full-time
Onsite
Senior Level
5+ years expAstera Cancer Care is dedicated to providing excellence in patient care within their communities in New Jersey and Pennsylvania. The Manager of Research Operations is responsible for ensuring the integrity, quality, and compliance of clinical trials, overseeing research coordinators, and collaborating on workflows to support clinical trial operations.
Clinical TrialsHealth CareHealth DiagnosticsHospitalOncology
Responsibilities
Supervise clinical research coordinators, ensuring efficient workload distribution, performance optimization, and adherence to all regulatory and protocol-specific requirements
Collaborate cross-functionally to design, implement, and refine workflows, processes, and standard operating procedures (SOPs) that support quality and efficiency in clinical trial operations
Manage site qualification, initiation, and close-out visits with study sponsors to support the successful implementation and execution of clinical trials
Review new study protocols and informed consent documents with staff to ensure comprehensive understanding of study objectives, methodology, visit schedules, adverse event reporting, and safety monitoring
Oversee subject screening conducted by coordinators, ensuring eligibility assessments are thoroughly based on medical history, current health status, and protocol-specific inclusion/exclusion criteria
Ensure that all study-related patient visits are conducted in compliance with protocol requirements, including clinical procedures, assessments, and testing
Supervise investigational product (IP) 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; verify that all activities meet protocol, regulatory, and institutional standards
Serve as a key liaison with sponsor representatives and monitors, addressing protocol inquiries and supporting monitoring visits
Lead the review and dissemination of protocol amendments, safety notices, suspensions, and terminations with direct reports
Liaises with sponsor staff such as study monitors and assists direct reports in the preparation for and completion of 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 thorough preparation and participation
Uphold high standards of professionalism, confidentiality, and patient-centered care at all times
Perform other related duties as assigned to support departmental goals
Qualification
Required
Bachelor's degree in biology, life sciences or equivalent
At least 5 years of clinical research experience
Preferred
Previous supervisory experience
Benefits
Medical
Dental
Vision
Life
Disability
HSA
FSA
401(k) plan with company contribution
Profit sharing
Tuition assistance
Employee referral bonus
Company
Astera Cancer Care
Astera Cancer Care offers care for cancer and blood diseases.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Edward Licitra
Chief Executive Officer
Amit Patel, M.D.
Physician Partner
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