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Posted Job Title
Quality Management Coordinator
Job Profile Title
Clinical Research Coordinator C
Job Description Summary
As a Quality Management Coordinator, your activities are critical to ensuring compliance with Good Clinical Practices (GCP). You will be designing and maintaining systems to aid in adherence to protocol documents, DAIDS and other sponsor requirements, assure 100% source documentation, and adherence to local, federal and institutional regulations. You will develop standardized collection methods and assure data quality through QA and QC methods, including maintaining accurate documentation of database development, extraction, query generation, data cleaning, and query resolution. You will perform audits of research activities against written protocols and Standard Operating Procedures (SOP); reviewing SOP's and updating formatting to comply with our standards. You will be a central resource for research investigators and staff in the Penn HIV CTU regarding QM, QC, and QA activities. You will prepare reports and assist with grant writing activities. You will supervise data management activities in the Therapeutic and Prevention CRSs. You will perform pre-audit inspections and preparations; and with input from the Program Managers and investigators, use your discretion and independent judgment in providing recommended corrective actions to management and the study leaders.
Also, you will be able to provide guidance and training to staff as it relates to GCP and compliance with multilayered regulations and requirements.
The Penn HIV Therapeutic and Prevention Clinical Trials Unit has been in existence since 1992. We are a high performing, high volume and rapid paced clinical research program. We recruit, screen and enroll human subjects in complex investigations of novel therapeutic regimens, studies of HIV Cure strategies, and novel HIV prevention strategies including experimental HIV vaccines.
As a Quality Management Coordinator, your activities are critical to ensuring compliance with Good Clinical Practices (GCP) and all sponsor regulations. You will be performing audits of clinical research activities against written protocols and Standard Operating Procedures (SOP); reviewing SOP's and updating formatting to comply with our standards; You will be a central resource for all research investigators and staff in the Penn HIV CTU regarding QM, QC, and QA activities You will prepare reports and assist with grant writing activities. You will supervise data management activities in the Therapeutic and Prevention CRSs.Â You will perform pre-audit inspections and preparations; and with input from the Program Managers and Investigators, use your discretion and independent judgment in providing recommended corrective actions to management and the study leaders.
1) Design, maintain, and oversee implementation of systems to aid in adherence to protocol documents, GCPs, and regulatory requirements
2) Develop standardized data collection methods and assure data quality through QA and QC practices
3) PerformÂ audits of research activities against written protocols and Standard Operating Procedures (SOPs)
4) Supervise Data Managers and data Entry clerks in Therapeutic and Prevention CRSs
5) Maintain up to date SOPs, implement training of all staff on SOPs
6) Design and maintain online system for documenting training of staff
7) Prepare reports and assist with grant writing activities
8) Use discretion and independent judgment in providing recommended corrective actions to management and the study leaders.
9) Serve as a content and process expert resource to faculty and staff within the HIV CTU
10) Perform additional duties as assigned
Bachelor's degree in life or social sciences and 4-6 years of experience in a clinical research data or quality management role or an equivalent combination of education and experience required;Â 5-7 years preferred
Experience working in GCP environment and strong knowledge of GCPs required
Experience in HIV related clinical research is strongly preferred.Â
Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a mustÂ
Strong analytical skills and attention to details required
Excellent interpersonal and written communications skills a must
Must have demonstrated experience meeting critical deadlines.Â
Experience with Microsoft word, excel required. Proficiency with EDC and other databases preferred.
Position contingent on funding
Job Location - City, State
Department / School
Perelman School of Medicine
$50,684.00 - $91,232.00
Affirmative Action Statement 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.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00015254
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.