Specialist, Clinical Research Lead

This position is with the Division of Cardiovascular Medicine (CVM) at the University of Maryland, Baltimore (UMB), supporting the department's mission in patient care, research, and education.

About the role

The Lead Clinical Research Specialist will oversee and guide clinical research programs, projects, and activities, ensuring compliance with protocols, federal regulations, and institutional standards. This role involves collaboration with faculty, staff, and external partners to advance cardiovascular research and improve patient outcomes.

Responsibilities

• Lead and guide the highest technical research activities in a clinical setting, ensuring design, development, documentation, and implementation of research procedures and protocols.
• Develop, recommend, modify, and enforce policies, procedures, and methods for clinical research to meet evolving needs.
• Prepare and ensure compliance with Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) protocols.
• Coordinate and manage clinical research data, including analysis using statistical software (e.g., SAS, SPSS, R), data collection, entry, verification, and validation.
• Assist in developing site tracking tools to comply with federal regulations and data monitoring requirements.
• Independently clean, validate, and analyze research data for publications, journal articles, and grant proposals.
• Lead the development of project timelines, work plans, recruitment strategies, and progress tracking for research studies or clinical trials.
• Collaborate with Principal Investigators and regulatory staff on new protocol submissions, amendments, and renewals.
• Perform advanced clinical research activities, including data interpretation, development of data collection instruments (e.g., survey questionnaires), and ensuring clinical relevance of data.
• Maintain communication with participants and colleagues regarding protocol-specific information and research orders.
• Provide assessments and ensure protocol compliance during participant involvement in studies.
• Serve as a liaison with departments such as IRB, outside organizations, government agencies, and product representatives to promote efficient operations and resource use.
• Oversee day-to-day clinical research operations, including study initiation, execution, and completion.
• Manage participant interactions, including eligibility screening, recruitment, enrollment, informed consent, counseling, and obtaining medical history.
• Monitor budgets, negotiate and review budgetary matters, ensure quality control and safety compliance, and submit invoicing.
• Develop policies, procedures, and methods for laboratory experimentation and order supplies.
• Review relevant literature, develop conclusions, write reports, prepare and deliver presentations, and recommend appropriate actions.
• Review analysis and reports from less experienced research team members.
• Train and mentor research personnel on research protocols, IRB submissions, procedures, and policies.
• Serve as a subject matter expert, providing guidance to staff, faculty, and leadership.
• Develop protocol manuals and data collection instruments, participate in field visits, and respond to requests from individuals, institutions, and funding agencies.
• Participate in the design of research studies.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in a scientific field related to the research of the clinic.
• Five (5) years of clinical research experience, including three (3) years in the relevant research specialization.
• Master’s degree in a related field may substitute for two (2) years of experience.

Skills

• Knowledge of position requirements, regulations, and applicable laws.
• Proficiency in using applicable technology and systems.
• Strong verbal and written communication skills.
• Ability to work cooperatively and independently.
• Understanding and adherence to UMB’s core values: Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

Benefits

• Comprehensive benefits package prioritizing wellness, work/life balance, and professional development.
• Retirement program (pension or optional retirement plan/ORP) effective on date of hire.
• Generous paid leave package, including over 4 weeks of vacation accrued annually, 15 paid holidays, 3 personal leave days, and unlimited sick time accrual.
• 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).

Pay

$80,500.00 - $93,000.00 (commensurate with education and experience).