Quality Management Coordinator

Location
Pennsylvania, United States
Salary
$50,684.00 - $91,232.00
Posted
05 May 2020
End of advertisement period
05 Jul 2020
Ref
JR00015254
Contract Type
Permanent
Hours
Full Time

University Overview

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.

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.

Job Description

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.  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.

Duties:

  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. Perform  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

Qualifications:

  • 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; 5-7 years preferred
  • Experience working in GCP environment and strong knowledge of GCPs required
  • Experience in HIV related clinical research is strongly preferred. 
  • Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must 
  • Strong analytical skills and attention to details required
  • Excellent interpersonal and written communications skills a must
  • Must have demonstrated experience meeting critical deadlines. 
  • Experience with Microsoft word, excel required. Proficiency with EDC and other databases preferred.
  • Position contingent on funding

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$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.

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