The University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center is seeking a Senior Research Quality Improvement & Compliance Analyst
to assist the Quality Improvement Manager to monitor and audit the operations of clinical trials conducted at the Cancer Center to ensure all safety and governmental regulations are met.UMB offers a comprehensive and competitive benefits package to eligible employees. This position receives an annual leave package starting with 22 accrued vacation days, 14 floating and observed holidays, 15 sick days, and 3 personal days; comprehensive health insurance and retirement options; professional learning and development opportunities; flexible schedules and teleworking options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.UMB requires all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.Primary Duties:
- Ensure monitoring activities are completed in accordance with University of Maryland Greenebaum Comprehensive Cancer Center SOPs, FDA regulations, and Good Clinical Practices.
- Conduct on-site and remote, study monitoring and site management.
- Monitor electronic data capture (EDC) systems and generate/resolve queries in sponsor database. Verify source documents, other trial records and CRFs are accurate, complete, and legible and that CRF entries reflect the source.
- Conduct qualification, initiation, interim, and close-out co-monitoring visits.
- Ensure Trial Master File (TMF) is accurate and complete throughout the lifecycle of the project.
- Assist with site audits and site quality management activities as needed.
- Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current developments in the assigned applicable therapeutic areas.
- Provide monitoring guidance and support to research staff and assess CRO activities related to sites and data management.
- Generate monitoring summary reports and communicate these findings to investigators, research staff, and data safety monitoring committee, as applicable.
- Help research staff prepare for external audits.
- Assist in the development and execution of internal quality management processes to ensure compliance with research requirements. Assist in identifying areas of risk and implementing corrective action plans. Facilitate resolution of regulatory issues as needed.
- Research and remain abreast of federal, state, and local laws as well as University policy to identify changes regarding statutes and rulings that might affect research projects and compliance. Provide information to researchers of changes and assist in devising strategies to successfully implement required updates.
- Perform other duties as assigned.
Bachelor’s in nursing, life science, healthcare administration, public health, policy, law or related field of the research. Master’s preferred.Experience:
Two (2) years of experience in clinical and/or laboratory research or related experience involving regulatory compliance issues.Other:
Related experience may be substituted for education.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:
Commensurate with education and experience.UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Staffing department at [email protected]
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. Job:
Reg or CII Exempt StaffShift:
School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer CenterJob Posting:
Jan 18, 2022Unposting Date: