Drexel University Hiring for Executive Director for Research Quality Assurance at Philadelphia, Pennsylvania Full Time

Executive Director for Research Quality Assurance
Job no: 501233
Work type: Full-Time
Location: Hybrid/Flexible Work Arrangement
Categories: Drexel University, Office of Research & Innovation

Job Summary
The Executive Director of Research Quality Assurance is committed to the highest standards of compliance to ensure that all research activities undertaken by faculty, staff, and students will be conducted in accordance with strict ethical principles, good clinical practice (GCP), and in compliance with federal, state and institutional regulations and policies.
Reporting to the Associate Vice Provost for Research Compliance and Regulatory Affairs, the Executive Director of Research Quality Assurance is responsible for developing, maintaining, and ensuring the effectiveness of quality programs and documentation to assure compliance and provide guidance in quality-related areas. This includes oversight and execution of routine and directed monitoring, management of investigator-initiated IND and IDE submission processes and risk assessments, as well as the development of guidance’s, standard operating procedures, and policies for the Drexel University’s Office of Research and Innovation (ORI) and the Research Community, including faculty, students, and study personnel.
Critical is the proactive collaboration led by the Executive Director with other ORI programs and offices, including but not limited to the Human Research Protection Program, Institutional Animal Care and Use Office, Research Compliance, Office of Sponsored Programs, Office of Applied Innovation (Technology Commercialization), as well as institutional offices, departments or programs and Drexel University’s researchers. This collaboration will help to ensure appropriate and coordinated monitoring, support, trainings, policies, and procedures.
Essential Functions
Provide oversight, develop, and maintain a monitoring program. This monitoring program will be responsible for routine and directed monitoring. This monitoring may include human subjects research (e.g., GCP, IRB, FDA, AAHRPP), animal research (e.g., IACUC, USDA, OLAW, AAALAC), conflict of interest (e.g., DHHS, NIH, FDA), financial and billing monitoring related to research (e.g., NIH, NSF, FDA), as well as other focus areas identified by ORI. Program components include but are not limited to:
create, implement, and provide oversight for routine and directed monitoring plans * develop and maintain templates for reports, communications, material collection and responses
develop and maintain communication processes for observations and deficiencies
establish and maintain policies, procedures and guidance on monitoring program
create, maintain and provide training based on feedback, observations and deficiencies
conduct routine and directed monitoring visits by documentation review, provide JIT training or insight, reference applicable policies and procedures, and provide insight to corrective and preventative action plans.
provide support for regulatory inspections and external monitoring visits
Provide oversight, develop, and manage a centralized IND/IDE Support Program
Provide a comprehensive, centralized support program for FDA submissions of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE) applications when Drexel University or its agents will be named as sponsors. This is accomplished by developing guidelines, procedures, and processes in alignment with regulations, best practice, and management of the implementation through :
Developing an intake and maintenance process for IND’s and IDE’s.
Collecting documentation as required by the FDA or other regulatory agency’s
Providing consultation to investigators/researchers on application process, event reporting, renewal processes, and annual progress reports
Monitoring the IND’s and IDE’s, including those involving external sites
Training and educational sessions
Work directly with the Associate Vice Provost for Research Compliance and Regulatory Affairs to develop and maintain ORI’s guidelines, procedures and policies framework to ensure appropriate development and maintenance of evidenced-based guidelines, ORI specific procedures and serve as a workgroup leader to facilitate clarity and transparency for ORI. This includes but is not limited to:
Lead, participate and/or collaborate in workgroup meetings with key stakeholders throughout Drexel University,
Conduct literature, documentation, and regulatory review to prepare drafts, or recommended revisions
Execute a communication plan across department leaders, researchers, ORI staff, and other stakeholders.
Other duties as assigned
Required Qualifications
Bachelor’s Degree or
A minimum of 10+ years progressive work experience in research with experience in three or more of the following areas:
monitoring/auditing
IRB
IACUC
research administration
clinical trials
regulatory specialist/study coordinator.
Direct Experience in applying requirements in three or more of the following areas/sub-areas:
Human subject research regulations including but not limited to FDA (21 CFR part 50, part 54, part56, part 312, and part 812), OHRP(45 CFR 46)
Animal Welfare research regulations, including but not limited too, Animal Welfare Act, Title 7, Chapter 54, Animal Welfare Regulations, Title 9, Chapter 1
DHHS- 45 CFR part 94
NIH-Grants Polity Statement
NIH-Health Research Extension Act
ICH-GCP
AAHRPP
AAALAC
NIST Security Standards
Ability to work independently, problem-solve and initiate program-level implementations effectively.
Superior writing and communication skills
Proficiency in Microsoft Office including Outlook, Excel, Teams
Comfort working in a hybrid environment
Ability to pivot in an actively changing environment.
Experience reporting to institutional leadership on observations, project, program or institutional deficiencies, and implementing solutions successfully as appropriate.
Preferred Qualifications
Masters or Ph.D in a scientific discipline
Proven skills and experience in building, leading, and developing quality functions in a collaborative environment.
Physical Demands
Typically sitting at a desk/table
Typically standing, walking
Location
Hybrid/Flexible Work Arrangement, Philadelphia, PA
Additional Information
This position is classified as Exempt  with a salary grade of P. For more information regarding Drexel’s Professional Staff salary structure,
Please review the  for some information on our benefits offerings.
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: Jun 16 2023  Eastern Daylight Time
Applications close: Jul 16 2023  Eastern Daylight Time

Drexel University is an Equal Opportunity/Affirmative Action employer, welcomes individuals from diverse backgrounds and perspectives, and believes that an inclusive and respectful environment enriches the University community and the educational and employment experience of its members. The University prohibits discrimination against individuals on the basis of race, color, national origin, religion, sex, sexual orientation, disability, age, status as a veteran or special disabled veteran, gender identity or expression, genetic information, pregnancy, childbirth or related medical conditions and any other prohibite