The University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a Research Quality Improvement & Compliance Analyst to coordinate with regulatory and clinical coordinators. This position will also manage a caseload of clinical trials data for multiple oncology disease areas as it pertains to regulatory documentation, such as: collection and filing of medical licenses and CVs, signature collection, dissemination of updated documents, etc. This position serves in support of the regulatory team offering guidance to the UMGCCC Clinical Research Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards. This position has a fully remote schedule with one in-person meeting per quarter requirement.

The UMGCCC is a National Cancer Institute (NCI)-designated comprehensive cancer center which conducts innovative basic and clinical research that will impact the understanding and treatment of cancer around the world and seeks to provide state-of-the-art clinical care to cancer patients in Maryland and beyond.

Primary Duties:

• Responsible for collecting, tracking, and analyzing data pertaining to regulatory documentation.
• Maintains up-to-date department information including faculty medical licenses, CVs, lab certifications, staff training certifications, etc. necessary to maintain compliance with study protocols. Coordinates and maintains data reports and database files on progress of research studies.
• Receives, inventories, enters, and organizes collected data and regulatory documents.
• Prepares and presents regulatory reports for presentation or submittal to sponsoring agent, Principal Investigators, and staff. Prepares and responds to audits conducted by study sponsors.
• Assists in the preparation of initial and ongoing IRB submissions and proposals and maintains regulatory files for all research studies.
• Determines reliability of data sources by evaluating information, determining errors, and notifying responsible parties.
• Performs other duties as assigned.

Qualifications:

Education: Bachelor's degree in Nursing, Life Science, Healthcare Administration, Public Health, Policy, Law, Information Management, Biology, Health, or Social Sciences, Public Policy, Mathematics, Statistics or another field of study related to the research.

Experience: One (1) year of experience in clinical and/or laboratory research or related experience involving regulatory compliance issues.