The University of Maryland, Baltimore Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a full-time, exempt Senior Research Quality Improvement & Compliance Analyst to serve as a Clinical Trial Startup Specialist and Regulatory Assistant. This position coordinates and manages the startup process for all new studies in the Clinical Research Management Office, as well as a maintains regulatory transactions responsibilities for a caseload of clinical trials in multiple oncology disease areas.

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.

Fully remote work schedule with on campus meetings as needed but not to exceed once per quarter. 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:

• Execute and administer research implementation processes and study start up activities for new cancer trials, which include the identification and assessment of areas of research compliance risk and vulnerability and implement recommendations to ensure appropriate corrective actions. Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines. Provides process improvement recommendations and assist in the design and development.
• Maintain records and study startup portfolio with information regarding status, prior completed steps, and sponsor contacts for each trial. Request and record information from other department staff to aid in completion of startup documents.
• Serves as the point of contact for Shared Investigator Platform (SIP). SIP is a multi-sponsor collaborative solution for clinical trial site selection, start-up communications and management.
• Establishes effective communication channels and acts as liaison between the program and officials within and outside the institution. Share frequent updates with Principal Investigators (PI) and respond to PI question. Provide proactive communication with sponsors to keep them informed of next steps and estimated timelines.
• Collects, compiles, and organizes department's data pertinent to various ongoing studies. Analyzes, summarizes, and communicates this information to appropriate officials. Maintains departmental information ensuring up-to-date faculty CV's, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements. Maintain complex files and electronic document management systems. Maintains document inventory, storage and retrieval. Prepares and responds to audits conducted by study sponsors. Responsible for the collection, filing, and maintenance, of regulatory documents. Generate numerous standard computer reports as needed.
• Assists in planning and coordinating regulatory activities of a program, such as assisting in the formulation and preparation of the organization's project proposals, protocols, and regulatory reports. Assist with the preparation of initial and ongoing institutional review board (IRB) submissions, maintains Regulatory Files for all Research Studies.
• Provides support with the training of new employees on regulatory policies and department practices.
• Assists in the management of assigned program or supervision of an operational unit. Assist in the planning and implementation of policies, practices, organization and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards.
• Assists in or conducts studies and analyses of programs, organizations, procedures, or systems of limited scope or assists senior specialists in more complex projects.
• Consults with program head and administrative officials regarding policies, trends, and interpretation of data and program needs following specific instructions.
• Conducts basic efficiency, time and cost studies and analyses of work processes and systems. Iterate documents, messages, and source information to continuously improve the study startup process. Prepares simple statistical tables and charts, staffing patterns, workflow and organization charts.
• Performs other duties as assigned.

Education: Bachelor's degree 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: Approximately $59,000 - $66,000, 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 HRJobs@umaryland.edu .

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 HRDiversity@umaryland.edu . Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.