Research Compliance Analyst

University of California - San Francisco; San Francisco (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

The University of California - San Francisco is seeking a Research Compliance Analyst to provide regulatory guidance and support to the research leadership team. This role involves preparing, submitting, and tracking IRB documents for clinical trials and assisting in the preparation of research grants and progress reports.

Ideal candidates will have a Bachelor's degree, at least 1 year of relevant experience, and knowledge of federal and state regulations. Effective communication and organizational skills are essential, along with the ability to work collaboratively in a dynamic environment.

Qualifications

• Bachelor's degree in related area and/or equivalent experience/training.
• Minimum 1 year of related experience.
• Knowledge of Federal and State regulations and policies.

Responsibilities

• Provide regulatory guidance and support to the research leadership team.
• Prepare and submit IRB documents for clinical trials.
• Assist with writing and production of newsletters and documents.

Skills

Problem-solving

Effective communication

Time management

Organizational skills

Customer service

Education

Bachelor's degree in related area

Tools

Library software (EndNote)

Personal computer software

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.