Rutgers, The State University of New Jersey is seeking a Director Clinical Research Unit in the Department of Medicine, within the New Jersey Medical School.
Under the general direction of the Director of the Center for Emerging Pathogens, the Director, Clinical Research Unit position is charged with the executive level management of the Division's international and domestic clinical research portfolio. Assures that clinical research conducted within the division, including projects conducted on-site, as well as those at international sites, are conducted according to Good Clinical Practice guidelines as well as applicable international, federal, and local regulations and guidelines.
Among the key duties of this position are the following:
Serves as a clinical research leader for the Division of Infectious Diseases (ID). In conjunction with physician leadership, promotes cohesive, coordinated and innovative clinical research program development.
Under the direction of the ID Division Chief, establishes research program goals and objectives; sets priorities; assures that current program activities are consistent with programs goals, objectives and priorities.
Actively seeks out new international collaborations; assesses capabilities of new international sites to conduct clinical research by evaluating site infrastructure requirements (i.e. Institutional Review Board, investigator and staff experience, access to subject population, clinical facilities, clinical laboratory capacity, etc.) Serves as a clinical and regulatory compliance point-of-contact for funding agency program officers for international clinical research projects, as well as other internal and external constituencies.
Serves as a clinical project manager for implementation of new international protocols. Using project management techniques, sets timelines for protocol start-up activities at collaborating sites, assures study start-up timeline targets are achieved, and problem-solves with sites as needed in start-up activities.
Conducts site staff training on the basics of conducting clinical research and Good Clinical Practice guidelines as well as protocol-specific training. Develops/implements technology-based solutions to provide training in a cost-effective manner.
Responsible for the oversight of regulatory file maintenance for clinical research studies conducted at international sites. Establishes standard operating procedures in this regard and assures that all files are up-to-date with IRB correspondence, Institution FWAs, sponsor correspondence and all essential documents, as required in accordance with applicable regulations, guidelines and award terms.
Directly or indirectly supervises division international clinical research staff, consistent with established personnel policies and procedures and regulatory agencies. This includes, but is not limited to, hiring, orientation, evaluation, and progressive disciplinary actions, as needed. Oversees the performance of staff, including role expectations and performance reviews, provides feedback to administrators regarding their performance, and ensures that staff qualifications are consistent with job responsibilities.
Provides technical assistance as needed on the division's domestic clinical research quality assurance plan. Assists with the development, maintenance and evaluation of standard operating procedures as they relate to the conduct of quality assurance audits and adjusts procedures in accordance with sponsor mandates. Assists with training staff on GCP, data collection and source documentation guidelines, as needed.
Minimum Education and Experience:
Master’s or Doctorate in a Health Related area.
Requires 5-10 years of clinical research experience that includes international sites and a leadership position based in an academic medical center.
Required Knowledge, Skills, and Abilities:
Proven ability to successfully deliver a wide range of projects within critical time frames and challenging budgets.
Demonstrates working knowledge of regulatory requirements.
Maintains current knowledge base of industrial, Food and Drug Administration (FDA), Good Clinical Practice (GCP) guidelines, and Institutional Review (IRB) policies.
Demonstrates sound knowledge of GCP guidelines and the Code of Federal Regulations (CFR).
Outstanding human relations and leadership skills, and the ability to function in a team environment.
Demonstrated knowledge of how to accomplish superior performance in a unionized environment.
Certification in clinical research (CCRC, CCRP, CHRC, etc.).
Salary: 114,359- 144,651- 174,954
Posting Number: 19ST4323
Location: Newark (RBHS)
Internal Number: 102681
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.