Protocol Analyst

at  Purdue University

Job Description
Req Id: 34487
Job Title: Protocol Analyst
City: REMOTE
Job Description:
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The Protocol Analyst will implement the operations of the Human Research Projection Program (HRPP). Review research proposals for regulatory compliance and ethical responsibilities and assist investigators with achieving compliance. Identify deviations from approved procedures and expectations and recommend corrective actions. Develop and provide educational programs to investigators who use the HRPP. Partner with faculty and other University personnel in building and sustaining an effective and efficient HRPP, which supports a world-class research institution. Monitor developments with changing requirements of sponsors and collaborators. Make decisions independently. Identify and develop new practices and procedures that can increase the level of service provided to faculty, the Institutional Review Board (IRB), and external partners.
This is a REMOTE position.

EDUCATION AND EXPERIENCE

Qualified candidates will need:

• Bachelor’s degree in a related field
• Two (2) years of experience in IRB administration, research, regulatory compliance with human subjects, or research administration
• In lieu of degree, consideration will be given to an equivalent combination of related education and required work experience; Associate’s + 4 years’ experience or HS/GED + 6 years of experience

Skills needed:

• Ability to analyze, interpret and implement Federal regulations and University policies and procedures related to academic research studies with human subjects.
• Motivated individual with ability to efficiently multi-task, work under pressure, handle frequent interruptions and meet deadlines.
• Ability to identify and determine problems, analyze information and implement solutions.
• Capable of taking initiative, assuming responsibility and handling confidential information with discretion.
• Ability to work independently and contribute to a team environment.
• Must possess a learning orientation to changing technology.
• Strong oral and written communication skills.
• Excellent customer service skills and professionalism in dealing with external business partners, students, faculty, and staff.
• Exceptional interpersonal skills with the ability to influence and build working relationships among a diverse workforce at all levels.
• Strong organizational and time management skills with emphasis on accuracy and attention to detail.
• High proficiency in software: Microsoft Word, Excel, and Outlook (Electronic email/Calendaring) and internet research skills.
• Broad knowledge of research methods and terminology.

Nice to have:

• HRPP/IRB experience

WHO WE ARE:

Purdue is a community built on collaboration, with global perspectives, Boilermaker pride and endless opportunity to live, learn and grow. Join us and contribute to our culture.

• Operations: Review research submissions and ensure that they are ready for IRB review. Advise IRB members on regulatory issues presented. Manage HRPP records (hard copy, electronic files, and database) in compliance with Federal regulations and University policy. Monitor records for completeness and data errors. Resolve deficiencies. Monitor IRB approved studies and IRB files for compliance. Write detailed, factual reports identifying both compliance and non-compliance. When appropriate, recommend remediation plans. Identify and develop new practices and procedures that can increase the level of service provided to faculty, the Institutional Review Board (IRB), and external partners. Manage multiple priorities and projects while maintaining attention to detail. Prioritize work in order to complete assignments on a timely basis.
• Collaborate with Other Areas: Monitor developments with changing requirements of sponsors and collaborators. Build trusting relationships with faculty and students who use the HRPP. Educate faculty members and students on the HRPP requirements and processes.
• Support the IRB: Conduct non-exempt protocol pre-review and ensure protocols are IRB review-ready before they are submitted to the IRB. Interpret vague Federal regulations and their application to unique fact patterns. Oversee scheduling of IRB meeting and agenda preparation, ensure quorum and prepare meeting minutes. Draft and issue formal communications to investigators informing them of the IRB’s decisions/requirements