Director, Clinical Research Operations

Director, Clinical Research Operations

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Job Responsibilities : The Director, Clinical Research Operations will report to the Director of Fiscal Operations of the Department of Radiology Research with a dotted line reporting to the Vice Chair of Clinical Research. The Director, Clinical Research Operations is responsible to ensure that translation of science is achieved by managing clinical trials with investigators within the Department of Radiology. Initially the role will be focused on assessing the clinical research landscape in the Department of Radiology. Upon completion of assessment, the Director will develop and execute plans for a clinical research central structure within the Department of Radiology. The Director will lead Operations teams prior and subsequent to trial execution. Additionally, the Director will manage / supervise the clinical and administrative personnel, assuring that each clinical trial meets patient care expectations and that they are conducted in accordance with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously. The Director will supervise the allocation of resources to facilitate clinical and operational aspects of trials. Central to the position is meeting all reporting requirements of all external review organizations, most notably the Food and Drug Administration (FDA). In addition to clinical trial management, the Director is responsible for working with the Managers of Clinical Research Finance Operations to establish the budget required to meet trial goals and to allocate the financial resources needed to assure that each clinical trial is executed fully. The Director is also responsible for the development and implementation of innovative process ideas that impact clinical trials management and for the implementation of clinical operations quality systems, document management, and quality control processes. At all times the Director is expected to remain actively engaged in organizational goals with particular focus on departmental program goals and objectives. Perform other duties and responsibilities as assigned.

Qualifications : Bachelor's degree and 7-10 years of related experience or an equivalent combination of education and experience required; Master's Degree and 5-7 years of related experience preferred.

Job Location - City, State : Philadelphia, Pennsylvania

Department / School : Perelman School of Medicine

Pay Range : $124,500.00 - $124,500.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement : The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements : Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.