QA/QI Analyst

Overview

Apply online at https://careers.drexel.edu/en-us/job/494541/analyst-qaqi

Job no: 494541
Work type: Full-Time
Location: Center City
Categories: Office of the Provost, Drexel University, Professional Staff

About Drexel

Drexel is a comprehensive global research university ranked among the top 100 in the nation. With over 24,000 students, Drexel is one of America's 15 largest private universities. Drexel is one of Philadelphia's top 10 private employers, and a major engine for economic development in the region. Drexel has committed to being the nation’s most civically engaged university, with community partnerships integrated into every aspect of service and academics.

Job Summary:

The QA/QI Analyst provides program assurance for research involving human subjects at Drexel University, including its applicable affiliates ad ensures that the research activities are respected and treated with the accordance of federal regulations, Institutional Review Board (IRB) approved protocol, and institutional operating procedures.

Essential Functions:

Lead QA/QI Initiatives Including:

• Coordinate and conduct post-approval monitoring of areas human subject research activities for compliance with IRB approved protocols, institutional policies, federal laws and regulations and ethical principles for the use of human subjects in research.
• Coordinate and conduct post-approval monitoring of areas human subject research activities for compliance with IRB approved protocols, institutional policies, federal laws and regulations and ethical principles for the use of human subjects in research.
• Implements policies and procedures for monitoring all research activities approved through human research protection program.
• Remain knowledgeable about current federal regulations and pending changes.
• Generate reports on areas visited, recommend corrective and preventative action plan (CAPA) maintaining compliance database.
• Conduct training and educational activities.
• Assist with internal inspections, external inspections, site visits and follow up activities.
• Provide expertise and consultation related to regulatory and policy issues.
• Provide direction, training, and guidance to the principal investigators and their research teams on all matters related to research conducted at Drexel University.
• Collaborate with central administrative departments i.e IRB, pre-award contracts, general counsel, biosafety, radiation safety, export control, pre-award research accounting services as needed to identify and mitigate compliance risks in order to protect the interests and reputations of the institution and faculty researchers. 

Develop and Maintain QA/QI Web Presence including:

• Coordinate and manage QA/QI website to ensure content is current and accurate for all QA/QI activities.
• Remain knowledgeable about current IT/internet/electronic issues in relation to research.
• Collaborate with the QA/QI team to develop and maintain an effective electronic tracking system and methods for troubleshooting issues and data maintenance.
• Be familiar with the responsibilities of all functional areas of the Office of Research and team with other OR staff to work on special projects, including maintaining department web information.

Become involved in the Drexel Community to Enhance understanding of QA/QI including:

• Encourage and support faculty in the pursuit of external support for research activities.
• Promote and cultivate relationships with faculty and university administrators.
• Participate in Office of Research & Innovation or University-related committees and/or task forces.

Perform special projects and other responsibilities as required and or needed.

Required Qualifications:

Bachelor's degree. A minimum of 3 years experience.

Preferred Qualifications:

Bachelor’s degree required, preferably in one of the medically related sciences. Master’s degree in medical research related sciences preferred.

Other Requirements:

• A minimum of 3 years career experience of successful performance in human subject research or research-related position with clear relevance to regulatory compliance and research involving human subjects is required.
• Familiarity with generally accepted research principles.
• Demonstrate ability to work under pressure, meet deadlines and process large amounts of information.Demonstrate ability to work as a member of a complex support team.
• Demonstrate the ability to manage complex reviews of operations involving human subject research.
• Possess a thorough understanding of federal regulations pertaining to research at a level sufficient to function independently as an advisor to faculty and staff.
• Possesses the ability to interpret research protocol information in relation to federal guidelines and institutional policies, exercise sound independent judgment and make recommendations and/or decisions regarding research activities for discussion and support with the research team.
• Demonstrate the ability to use a computer to generate reports, charts, and presentations with Microsoft Office products.
  Possess excellent time management skills with the ability to independently prioritize organize and efficiently deal with multiple ongoing activities.
• Demonstrate the ability to initiate and complete routine and nonroutine tasks.
• Possess good written communication skills including the ability to conduct training presentations in front of large or small groups.

Individuals with certification in one or more of the following will be given preference:

• Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), or Certified IRB Professional (CIP)

Physical Demands:

Sitting at a desk/table.

Standing, walking.

Lifting up to 25lbs.

Job Location:

University City.

Additional Information:

This position is classified as exempt with a salary grade of K. For more information regarding Drexel’s Professional Staff salary structure, https://drexel.edu/hr/career/ducomp/salstructure/

Special Instructions to the Applicant:

Please make sure you upload your CV/resume and cover letter when submitting your application.

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Advertised: Feb 26 2020 Eastern Standard Time
Applications close: Mar 26 2020 Eastern Daylight Time