Job description

Under minimal supervision, the Research Compliance Analyst will provide regulatory guidance and support to the research leadership team, faculty, and other research staff. This will include preparation, submission, and tracking of IRB documents for clinical trials and other human subjects research sponsored by industry, foundation/non-profit, state, and federal sponsors. In addition, the position will support the research leadership team by preparing and submitting research grants, subcontracts, and progress reports for ongoing funded research. The incumbent will work closely with the research leadership team in assessing and calculating metrics for the research programs. The incumbent will assist with the writing and production of newsletters and other documents distributed by the research program. Required 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, issues; listen, interpret and confirm understanding of others' communications; and be objective. • Effective, efficient and tactful oral and written communication skills. • Time management skills and the flexibility to accommodate changing priorities in unit. • Ability to work in a team oriented setting, to prioritize work, and to 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 and understanding of federal, state, and university regulations for clinical research • Experience and 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. Preferred Qualifications • Ability to use library software (EndNote) and University library resources to identify and catalog publications by Department faculty and trainees; ability to obtain publications in hard copy or .pdf format. • Relevant compliance certification (if applicable) preferred.

Requirements

Must-haves

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, issues; listen, interpret and confirm understanding of others' communications; and be objective.
Effective, efficient and tactful oral and written communication skills.
Time management skills and the flexibility to accommodate changing priorities in unit.
Ability to work in a team oriented setting, to prioritize work, and to 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 and understanding of federal, state, and university regulations for clinical research
Experience and 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.

Nice-to-haves

Ability to use library software (EndNote) and University library resources to identify and catalog publications by Department faculty and trainees; ability to obtain publications in hard copy or .pdf format.
Relevant compliance certification (if applicable) preferred.

Application prep

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Keywords to mirror

gcp

Platform: oracle-cloud
Effort: medium

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