QA/QI Manager

Job Summary

The Office of Research & Innovation is seeking a QA/QI Manager. The QA/QI Manager provides program assurance for research involving human subjects at Drexel University, including its applicable affiliates and ensures that the research activities are conducted in accordance with all applicable requirements including, but not limited to, federal regulations, Institutional Review Board (IRB) approved protocol, accreditation standards, and institutional operating procedures.

Essential Functions

Coordinate and conduct post-approval monitoring of 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., as applicable for both internally facing (IRB) and externally facing (study level)

• Remain knowledgeable about current federal regulations and pending changes
• Generate reports on areas visited, and, when applicable, recommend corrective and preventative action plan (CAPA)
• Maintain compliance database
• Conduct training and educational activities
• Assist and conduct internal and external monitoring and auditing activities including inspections, site visits and follow up activities
• Coordinates the AAHRPP accreditation process by acting as a project manager for annual reports, re-accreditation applications, and other applicable reporting
• 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 to protect the interests and reputations of the institution and faculty researchers
• Collaborate with the Assistant Director of the IRB, when required, to conduct monitoring and audit activities for the IRB staff

Develop and maintain QA/QI website to ensure content is current and accurate for all QA/QI activities. Implements policies and procedures for monitoring all research activities approved through the human research protection program

• 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, IRB, and HRPP teams 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 & Innovation staff to work on special projects, including maintaining department web information

Provides education to the research community, the HRP staff, and IRB board members on relevant topics, regulatory changes, and other topics as identified in collaboration with the HRP Director

• 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

Manages the AAHRPP processes in collaboration with the HRP Director

Perform special projects and other responsibilities as required and or needed

Required Qualifications

• Bachelor’s degree in one of the medically related sciences
• A minimum of 5 years' experience, 3 years directly in the IRB
• A minimum of 3 years career experience of successful performance in human subject research 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)

Preferred Qualifications

• Bachelor’s Degree in one of the medically related sciences
• Master’s Degree in medical research related sciences

Physical Demands

• Typically sitting at a desk/table
• Typically standing, walking
• Lifting demands ≤ 25lbs

Location

Remote/University City, Philadelphia, PA – hybrid work schedule available

Additional Information

This position is classified as Exempt with a salary grade of L. 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.

Review of applicants will begin once a suitable candidate pool is identified.

Advertised:Aug 26 2022 Eastern Daylight Time
Applications close:Sep 26 2022 Eastern Daylight Time