Senior Research Quality & Compliance Lead

University of Maryland, Baltimore (UMB); Baltimore (MD); On-site; USD 84,000 - 95,000; Full time

Benefits offered by this job

Tuition remission for employees and/or

Flexible work schedules

Teleworking options

Paid leave package

Job summary

University of Maryland, Baltimore (UMB) seeks a Lead Research Quality Improvement & Compliance Specialist in the School of Medicine, Department of Radiation Oncology, to oversee research processes and regulatory compliance across IRB, FDA/IND submissions, and related activities.

The role requires advanced knowledge of research regulations, training researchers, and implementing quality management programs with strong leadership and communication skills.

Qualifications

• Bachelor's degree in nursing, life science, healthcare administration, public health, policy, or related field.
• Master's degree preferred.
• Four years of experience in clinical and/or laboratory research with regulatory compliance.
• Three years of direct experience in IRB, clinical trials, or research administration.
• One year of supervisory experience.

Responsibilities

• Lead the design, development, execution, and administration of the research process.
• Identify education and training needs and deliver training to researchers on regulations and ethical standards.
• Provide consultation on regulatory and ethical requirements to researchers and staff.
• Lead new protocols for FDA and IND submissions and prepare consent forms.
• Develop and oversee an internal quality management program for compliance and risk.
• Develop reports and communications for management and stakeholders.

Skills

Regulatory knowledge

Analytical thinking

Effective communication

Policy interpretation

Project coordination

Education

Bachelor's degree in nursing, life science, healthcare administration, public health, policy, or related field

Master's degree preferred

Tools

Quality document management software

Job description

University of Maryland, Baltimore (UMB) seeks a Lead Research Quality Improvement & Compliance Specialist in the School of Medicine, Department of Radiation Oncology, to oversee research processes and regulatory compliance across IRB, FDA/IND submissions, and related activities.

The role requires advanced knowledge of research regulations, training researchers, and implementing quality management programs with strong leadership and communication skills.