Research Compliance Analyst

About the role

The Research Compliance Analyst provides regulatory guidance and support to the research leadership team, faculty, and other research staff. Duties include preparation, submission, and tracking of IRB documents for clinical trials and other human subjects research sponsored by various sponsors.

Responsibilities

• Prepare, submit, and track IRB documents for clinical trials and other human subjects research.
• Support the research leadership team by preparing and submitting research grants, subcontracts, and progress reports for ongoing funded research.
• Assess and calculate metrics for the research programs.
• Aid in the writing and production of newsletters and other documents distributed by the research program.

Qualifications

• Bachelor's degree in related area and/or equivalent experience/training.
• Minimum 1 year of related experience.
• Independence, planning, and decision-making abilities to complete assigned duties.
• Knowledge of relevant Federal and State regulations and policies.
• Ability to solve problems, listen, interpret, and confirm understanding of others' communications, and be objective.
• Effective, efficient, and tactful oral and written communication skills.
• Time management skills and flexibility to accommodate changing priorities in unit.
• Ability to work in a team-oriented setting, prioritize work, and follow through on routine assignments with minimal direction.
• Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
• Excellent customer service skills, pleasant, helpful, and patient.
• Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
• Experience and knowledge of federal, state, and university regulations for clinical research.
• Knowledge and understanding of Institutional Review Board practices and guidelines.
• Knowledge and understanding of “good clinical practices” for clinical research.
• Excellent written communication skills required in order to write IRB-required documents and edit IRB documents written by others.
• Ability to pay careful attention to detail to ensure accurate and complete maintenance of regulatory documents, through strict adherence to university, state, and federal guidelines, and GCP guidance.