Research Quality Improvement & Compliance Analyst (Full-Time Telework)

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. Private, foundation, and government sponsors provide funding to the Cancer Center to provide medical research treatment to cancer patients.  

Benefits Information
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). 

UMB is a public university and constituent institution of the University System of Maryland.  All employees are expected to work primarily physically within the State of Maryland.

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.

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.
Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.

Knowledge, Skills, and Abilities:
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

Hiring Range: $57,000 - $60,000, commensurate with related education and experience.

UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.

If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request. You may also contact [email protected]. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.