Note: The job is a remote job and is open to candidates in USA. The University of Maryland, Baltimore (UMB) is seeking a Research Quality Improvement & Compliance Analyst to support the regulatory team at the Marlene & Stewart Greenebaum Comprehensive Cancer Center. This role involves managing clinical trials data, ensuring compliance with human research protection laws, and preparing regulatory reports and submissions.
Responsibilities
- 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
Skills
- 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
- One (1) year of experience in clinical and/or laboratory research or related experience involving regulatory compliance issues
- 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
Benefits
- Retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire
- 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
- Comprehensive health insurance
- Professional learning and development programs
- Tuition remission for employees and their dependents at any University System of Maryland school
- Flexible work schedules and teleworking options (if applicable per job)
Company Overview
The University of Maryland, Baltimore (UMB) was founded in 1807. It was founded in 1953, and is headquartered in Catonsville, Maryland, USA, with a workforce of 5001-10000 employees. Its website is http://www.mprc.umaryland.edu.