Rutgers, The State University of New Jersey is seeking an Associate Director Research Operations (Operations Manager/Scientist) within the Rutgers Contract Research Collaboratory (RC)2 Division of the Rutgers Institute for Translational Medicine and Science (RITMS).
The Associate Director, Research Operations will serve as a strategic partner to the Director in establishing, growing, and continuously improving the Rutgers Contract Research Collaboratory (RC)2. This individual will provide scientific, operational, and regulatory leadership across a diverse portfolio of industry-sponsored, federally funded, and investigator-initiated clinical research programs, translating sponsor clinical development objectives into high-quality, compliant, and efficiently executed studies.
Working collaboratively with investigators, sponsors, institutional leadership, and multidisciplinary research teams, the Associate Director will oversee portfolio planning, study feasibility, operational strategy, resource allocation, staffing, budget development, vendor management, and performance monitoring. The successful candidate will help develop standardized operating procedures, quality management systems, and operational metrics that promote efficiency, consistency, regulatory compliance, and continuous process improvement across the organization.
The Associate Director will play a central role in sponsor engagement and business development by supporting proposal development, protocol feasibility assessments, and strategic partnerships while ensuring studies are delivered on time, within budget, and to the highest scientific and regulatory standards. The position requires extensive knowledge of FDA regulations, ICH-Good Clinical Practice (ICH-GCP), IND and IDE studies, and the regulatory requirements governing multi-site clinical research.
As a member of the (RC)2 leadership team, the Associate Director will recruit, mentor, and develop high-performing staff while fostering a collaborative, inclusive, and accountable culture focused on innovation, professional development, and exceptional customer service. The individual will work closely with project management, clinical data management, biostatistics, regulatory affairs, and scientific leadership to build an integrated Clinical and Data Coordinating Center capable of supporting complex national and international clinical research programs. As a founding leader of (RC)2, the Associate Director will have a unique opportunity to shape the center’s strategic direction, operational infrastructure, and organizational culture while contributing to Rutgers Health’s vision of becoming a national leader in clinical research coordination and translational science.
Essential Duties and Responsibilities include the following:
- Serves as a senior sponsor-facing representative of the Rutgers Contract Research Collaboratory, supporting sponsor engagement, needs assessments, proposal development, scope-of-work development, budget strategies, bid-defense preparation and implementation, sponsor governance meetings, and identification of repeat or add-on opportunities.
- Oversees Rutgers Contract Research Collaboratory portfolio-level planning and execution in collaboration with the Director, including prioritization of studies, staffing models, workload distribution, operating budgets, vendor decisions, financial performance, and escalation of major scientific, operational, regulatory, or financial risks.
- Leads cross-functional project teams and governance discussions across sponsors, Rutgers stakeholders, investigators, vendors, and operational staff.
- Provides scientific and regulatory strategy support for industry-sponsored drug and device studies, including studies conducted under IND and IDE frameworks; advise sponsors and Rutgers teams on protocol gaps, execution risks, and practical options to improve study quality and feasibility.
- Drafts, critically review, or oversee scientific, operational, and regulatory documents, which may include protocols, synopses, project bids, informed consent templates, study manuals, clinical study reports, regulatory responses, sponsor presentations, standard operating procedures, and other study-specific materials.
- Partners with sponsors, investigators, regulatory experts, biostatistics, data management, clinical operations, and quality teams to ensure that study design and execution plans are aligned with applicable FDA, ICH GCP, institutional, and international requirements
- Oversees the development, implementation, and continuous improvement of the Rutgers Contract Research Collaboratory’s clinical research quality system, including SOP architecture, controlled documents, training expectations, audit/inspection readiness, issue escalation, CAPA processes, and risk-based quality management.
- Provides strategic oversight and management to Clinical Study Managers and other operational staff responsible for study start-up, activation, site feasibility, IRB/regulatory submissions, vendor coordination, study conduct, and closeout.
- Responsible for the hiring, firing, performance review and training of the research staff.
