"Director, Research Operations"

Position Summary

Rutgers, The State University of New Jersey, is seeking a Director, Research Operations for the department of Medicine at the New Jersey Medical School.

The Director of Research Operations will provide leadership, technical, and business oversight for international infectious diseases clinical research endeavors of the Center for Emerging Pathogens/Section of Infectious Diseases and its faculty investigators. He/she will provide strategic vision in the development, implement, and execution of clinical protocols funded by NIH/NIAID, specifically tuberculosis networks aimed to identify biological responses to eradicate tuberculosis. He/she will be responsible for the storage of epidemiological data, performing pertinent statistical analysis resulting from trials at network international site and assure high level performance and effective quality assurance/quality Control. He/she will direct operations within the Data Management Center assuring success in clinical research efforts, while in the field working directly with site personnel. The Director of Research Operations will provide guidance and recommendations for the growth and development of a research unit that is fiscally responsible and addresses the strategic plans of the organization. Critical in business development at corresponding international sites, identifying and accurately budgeting and performing cost analysis in determining the most cost-effective approach in parallel with protocols that are implemented.

Among the key duties of this position are the following:

• Provides key role in the development, execution, management and monitoring of Sponsored Research Program Portfolio. Serves as representative and support for Principal Investigator for institutional, sponsor and collaborator interactions across all issues relevant to research program conduct (i.e. financial, administrative/contractual and human subjects' compliance, clinical conduct, site monitoring and implementation).
• Provides operational expertise and designs strategic plans for program development and implementation. Works with investigators to maintain timeline of study objectives, strategize efficient use of resources, and tracks personnel activities in the field.
• Works with investigators and Rutgers staff in proposal generation and submission. Evaluates sponsor RFAs, proposes complex, multi-site budget allocations for inclusion in the proposals.
• Provides and implements strategic planning for international resourcing, shipping, data systems, processes and infrastructure for clinical sites funded by NIAID programs.
• Responsible for international operations, that coordinate and supervises overall responsibility for multiple projects, delivering through all lifecycle phases (proposal to close-out). Provides leadership in the development of projects and sub-projects and works closely with Principal Investigator(s), research directors, sponsors, institutional offices and cross-functional study teams.

Minimum Education and Experience

• Advanced degree (Master's or PhD degree) in a biomedical field, with specialization in infectious diseases epidemiology desirable.
• At least fifteen (15) years of experience in the development/proposal generation, study implementation, administration and coordination of human subjects/clinical and translational research in resource-poor international settings.
• Experience in the implementation of phase I/II/III IND clinical trials and/or large-scale observational studies with clinical, translational and basic aims/goals.
• Experience dealing with sponsored research and funding agency representatives and guidance.