Sr Clinical Research Operations Specialist

Duties: The Senior Clinical Research Operations Specialist is an integral part of the Operation Unit in the Office of Clinical Research (OCR). Under the direction of the Senior Director of Clinical Research Operations, the Senior Clinical Research Operations Specialist will work to promote, support and facilitate CLINICAL RESEARCH by acting as a central resource to the CLINICAL RESEARCH faculty and staff at the Perelman School of Medicine. The Senior Clinical Research Operations specialist will serve as a resource to develop an overall IT strategy to support CLINICAL RESEARCH within PSOM. The Senior Clinical Research Operations Specialist will be expected to develop workflows and standards around research clinical systems. The role will also be responsible for generating standard metrics from research inventory systems.
This position is responsible for providing support and project management for the IT CLINICAL RESEARCH infrastructure that includes: Work with the Senior Director of Clinical Research Operations to develop an overall IT strategy to support CLINICAL RESEARCH at PSOM; Serve as the operational project manager to lead the implementation and integration of a Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC); Serve as the liaison between the PennChart RESEARCH OPERATIONS team and other IT teams within OCR and PMACS; Implementation, workflow development and/or training with respect to CTMS and EDC platforms; Serve as the lead of the IT implementation project -run meetings, set agendas, create action items, project charters and set priorities for a wide variety of stakeholders in order to move overall systems project forward; Conduct QA review of systems data on an as needed basis and serve as a resource to the Penn community from a research systems standpoint; Generate metrics and data for senior leadership from research inventory systems; Ability to interact with a variety of stake holders to move the overall IT implementation project forward.

Qualifications: The minimum of a Bachelor's degree and two years of progressively responsible experience in business systems analysis and/or CLINICAL RESEARCH trial operations/project management or an equivalent combination of education and experience required. Master's degree and/or additional years of experience strongly preferred;
Understanding of data management best practices; direct experience with the development of workflows around document management; understanding of IT requirements and regulations that surround CLINICAL RESEARCH; ability to take initiative and think strategically; demonstrated ease and comfort working with a wide range of personnel; excellent communication and effective writing skills.

Reference Number: 40-30042

Salary Grade: C

Employment Type: Exempt

Org: SM-DN-Office of Clinical Research

Special Requirements:

Job Family: E-Information Systems/Technology