Overview
POSITION SUMMARY:
Under the direction of the Director or designee, the Regulatory and Compliance Specialist I is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures.
Responsibilities
ESSENTIAL DUTIES:
-Gather data, review, and triage the submissions of various initial and continuing review requests ensuring accuracy and the appropriate level of review according to the state and federal regulations
-Assess submissions for consistency with regulation & compliance requirements
-Track the metrics of the performance of processes (initial, continuing review, new information reporting, etc) as well as responses from investigators and research staff for resolution
-Ensure that delegated pre-review process communications for investigators are handled efficiently
-Prepare, review, and submit regulatory and compliance documents
-Coordinate training to the research community
-Coordinate central committee communication for meetings, agendas, approvals, etc.
-Provide support for all web changes and enhancements of information
-Compile data and assist in designing reports for internal and external audiences
-Prepare, maintain and revise procedures or instruction manuals, and integrate changes
-Perform other duties as required.
Qualifications
REQUIRED QUALIFICATIONS:
-Bachelor’s degree in science, a related field, or equivalent experience
-1-3 years of experience in research or regulatory/compliance administration or other relevant experience
-Experience in handling confidential and sensitive material
-Effective oral and written communication skills
-Ability to prioritize, problem-solve and work under pressure in a deadline-driven environment
Apply Here: www.click2apply.net/wglM5zsDJklwJiDjQf5Lzl
PI239666655