Data and Safety Monitoring Committee Coordinator

Location
Pennsylvania, United States
Posted
23 Oct 2018
End of advertisement period
23 Dec 2018
Ref
40-30078
Contract Type
Permanent
Hours
Full Time

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 has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

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. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

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.

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Reporting directly to the Data and Safety Monitoring Committee (DSMC) Manager within the Abramson Cancer Center and indirectly to the Chief ACC Compliance Officer- Clinical Research, the Data and Safety Monitoring Committee (DSMC) Coordinator is responsible for assisting the DSMC Manager with all aspect of coordination of the DSMC monthly and ad hoc meetings. This includes sending quality, compliance and safety queries to investigator and following the queries through to conclusion; researching pharmacovigilance issues in medical records and corresponding regulations to determine compliance with regulations for appropriate safety case studies; providing reports to the DSMC manager; reviewing Quality Control and Assurance issues identified by the Manager of Regulatory Compliance and taking appropriate corrective actions as defined by the DSMC and collecting metrics to be reporting to the DSMC and CCO-CR. Ensuring DSMC activities comply with all NCI expectations, tracking data in proprietary systems and reporting as necessary; prepares meeting agendas; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in research, and a written summary of controverted issues and their resolution. The DSM C Coordinator prepares written correspondence to investigators of applicable DSMC actions and decisions. The DSMC Coordinator reviews and records exceptions, deviations, and independent safety reviews; maintains minutes, DSMC rosters, DSMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. The DSMC Coordinator provides guidance on issues related to DSMC regulations and actions. The DSMC Coordinator participates, as assigned, in research community outreach and training activities; as well as DSMC member training and DSMC quality improvement initiatives including the review of existing DSMC policies and procedures. The DSMC Coordinator is responsible for maintaining a database of information related to DSMC activities and generating reports that are used by ACC leadership and the NCI.

Minimum of a BA/BS in a relevant discipline (biological sciences required) and 3-5 years of experience and knowledge directly related to clinical research or an equivalent combination of education and experience required; detailed knowledge of applicable regulations related to clinical research. Knowledge of the purpose, function and operations of a Data and Safety Monitoring Board is a strong plus. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.

This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties and responsibilities required of employees assigned to the job.

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.