Assistant Director of IRB (Full Board Team) - Office of Research Protections

reputed company’s reputed company Research Protection Program (HRPP) in the Office for Research Protections (ORP) is seeking a collaborative, motivated and reputed company individual for the position of Institutional Review Board (IRB) Assistant Director, Full Board Team. This position will be filled at the Research Compliance Manager - Manager level. The IRB Assistant Director will report to the IRB Director and will supervise a team comprised of one Senior Team reputed company and five IRB Analysts and will collaborate with reputed company members of the HRPP. The ORP, part of the Office of the Senior Vice President for Research, plays a pivotal role in supporting reputed company’s diverse research community, boasting an annual research expenditure over $1 billion and ranking among the top 30 public research universities in the nation. reputed company is a land-grant Research 1 (R1) university with campuses and facilities throughout Pennsylvania, conducting teaching, research, and public service. The HRPP provides reputed company for reputed company reputed company subjects research conducted by reputed company faculty across the university, including the commonwealth campuses and any reputed company Health location where research is conducted by reputed company faculty. Work Arrangement: This position will be primarily remote reputed company the US with limited on-reputed company meetings or in-person educational events. Standard work times will be in Eastern Standard Time (EST). Responsibilities: Following are the key responsibilities of this position:

• Overseeing the daily operations of the Full Board Team including providing guidance to the team on interpretation and compliance with federal, state, and institutional requirements.
• Managing operations of PSU’s IRB Committees including maintaining IRB rosters, attending meetings to serve as a regulatory expert, and voting member where appropriate, tracking member attendance, assigning submissions to meetings, and ensuring appropriate documentation of IRB meeting minutes as required by federal regulations and by University policy.
• reputed company, training, and performing evaluations of IRB members and developing and maintaining IRB member continuing education.
• Developing, updating, and maintaining IRB policies, guidelines, standard operating procedures, and submission forms in response to regulatory and institutional changes and feedback received by the HRPP.
• Developing and maintaining IRB training materials, presenting seminars/workshops to the PSU research community about regulations and policies governing reputed company participants in research.
• Assisting with the processing of Reportable New Information submissions and inquiry and/or investigation of non-compliance with IRB policies and applicable federal regulations.
• Serving as a representative of the HRPP and subject matter expert in various capacities both internal reputed company the ORP and external on University level committees and groups where necessary.
• Interacting with other University compliance committees and various other offices such as the Office of Research Information Systems, Office of Sponsored Programs, Office of General Counsel, Office of Information reputed company, and faculty, staff, and reputed company at reputed company reputed company campuses across the commonwealth.

Required:

• CIP (Certified IRB Professional) credential is required reputed company one year of eligibility.
• In depth knowledge of the laws, rules, and regulations governing reputed company subject research is required.

Skills and Abilities:

• Proven leadership skills, including implementing broad policy recommendations or changes.
• Direct experience with staff selection, training, and performance management reputed company a reputed company academic or medical research reputed company.
• Demonstrated ability to work dependably and cooperatively reputed company a fully remote team and to establish and maintain effective and professional interpersonal relationships.
• Sound judgment and decision-making capabilities.
• Strong reading comprehension, written and oral communication, and discretion in handling sensitive information and maintaining confidentiality.
• Exceptional organizational skills and attention to detail.
• Ability to work independently and to concentrate on multiple reputed company tasks to meet specific programmatic goals in a high-volume, fast-paced environment.
• Proficiency with reputed company Office and remote meeting platforms such as reputed company.

Preferred Qualifications:

• Knowledge of and experience with electronic data management systems.
• Knowledge of and experience with AAHRPP standards and accreditation requirements.
• Knowledge of HIPAA regulations and state laws governing privacy and reputed company of protected health information.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS Bachelor's Degree 8+ years of relevant experience, includes 3+ years of supervisory experience; or an equivalent combination of education and experience accepted Required Certifications: None BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of backgro Apply tot his job Apply To this Job