Astera-OneOncology
Manager, Research Operations
Astera-OneOncology, East Brunswick, New Jersey, United States, 08816
Manager Of Research Operation
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 Operation 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 the protection of the health, safety, and welfare of research participants. The position operates under the general supervision of the Director of Clinical Research and Principal Investigators. Core Responsibilities Include: 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. Qualifications: Bachelor's degree in biology, life sciences or equivalent At least 5 years of clinical research experience Previous supervisory experience preferred Work Environment: Office Travel to all offices as necessary
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 Operation 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 the protection of the health, safety, and welfare of research participants. The position operates under the general supervision of the Director of Clinical Research and Principal Investigators. Core Responsibilities Include: 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. Qualifications: Bachelor's degree in biology, life sciences or equivalent At least 5 years of clinical research experience Previous supervisory experience preferred Work Environment: Office Travel to all offices as necessary