Research Compliance Analyst

Job Summary

This position provides regulatory support to Internal Medicine’s Research Units, including Endocrinology, Infectious Diseases, Nephrology, and Rheumatology. Under the direction of the Clinical Research Supervisor, the Research Compliance Analyst ensures high-quality regulatory compliance across multiple studies and research units, working independently with minimal oversight to manage regulatory submissions, document oversight, and conflicts of interest requirements, applying strong working knowledge of clinical research regulations and standards.

The role supports protocol review, assists with protocol development and amendments, and ensures adherence to federal, state, and University policies. The incumbent also provides regulatory guidance to clinical research coordinators and other research personnel, contributing expert knowledge in compliance, documentation integrity, and inspection readiness.

This position will provide regulatory oversight across multiple divisions’ clinical research programs, including training junior clinical research coordinators and/or other support personnel. They will have knowledge of how to properly document these actions in accordance with all applicable laws, regulations, policies and procedures. Work is performed independently and with consultative direction of the Principal Investigator, supervisor(s), and Research Team.

1/25/2026 by 11:59pm: interviews may occur at anytime

• Bachelor's degree in a related field or a combination of experience, education or training required.
• Foundational experience as a clinical research coordinator (or equivalent)
• Knowledge and understanding of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), federal and Institutional Review Board guidelines.
• Experience in organizing tasks and set priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity.
• Experience working with computer systems and databases, including electronic medical records, eCOI, e-regulatory (CTMS and Oncore), and electronic data capture systems for clinical research.

• Extensive experience as a clinical research coordinator (or equivalent)
• Experience in independently organizing tasks and set priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity.
• Experience working with computer systems and databases, including electronic medical records, eCOI, e-regulatory (CTMS and Oncore), and electronic data capture systems for clinical research.
• Excellent skills to exercise discretion, initiative and resourcefulness and make independent judgments based on sound analysis.
• Leadership skills encompassing both training and ongoing mentoring of junior research team members.
• Organizational skills and attention to detail in maintaining large volumes of records.
• Ability to use analytical and problem‑solving skills for the identification and resolution of unique and unforeseen problems in a logical, timely, and often creative manner while maintaining the integrity of study protocols and legalities defined by the University, departmental and study policies and procedures.
• Oral and written communication skills to clearly and concisely provide information, explanations and instructions to, and to elicit information from participants, participant’s families, physicians, clinic staff and a wide variety of health care professionals with varying levels of ability to understand.
• Display writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.

• Ability to serve as a role model; demonstrate a customer-service orientation and hold self-accountable for achieving service excellence.
• Ability to maintain good working relationships with faculty, community-based healthcare professionals, staff and research participants.
• Ability to work cooperatively as a team…