The University of Maryland, Baltimore (UMB), Center for Vaccine Development and Global Health (CVD) brings together more than four decades of innovative and life-saving research on vaccines and infectious diseases. As an organized research center within the University of Maryland School of Medicine (UMSOM), CVD comprises a multi-disciplinary team of faculty and staff whose primary mission is to develop, evaluate, and implement vaccines and other interventions to reduce illness and mortality domestically and in less developed countries. We work to prevent and treat enteric and respiratory diseases, to reduce the threat of malaria and antimicrobial resistance, and to identify, understand and combat other tropic and emerging pathogens burdening low resource settings. Training is a critical component of our work to ensure the foundation for the next generation of scientists and researchers committed to our mission.

The CVD is seeking a Clinical Research Specialist to join our team.

Under general supervision of the Principal Investigator and Clinical Research Manager, the Clinical Research Specialist carries out key elements of a clinical research project. The project may include adult or pediatric populations. Responsible for timely completion of deliverables to meet the needs of the project, study sponsor, principal investigator and department administration.

Benefits:

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. This position is required to be vaccinated against COVID 19. For additional information on protocols and exemptions, please visit the COVID-19 website.

Primary Duties:

• Performs as a single specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. The position significantly contributes to the conduct of research.
• Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.
• Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. May obtain tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
• Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning. Check validity and accuracy of data ensuring compliance with quality control requirements and study relevance.
• Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data. May develop data collection instruments such as survey questionnaires.
• Maintains communication with participants and colleagues regarding protocol specific information and research orders. Provides assessments and ensure protocol compliance while participants are in a study.
• Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
• Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion. Assist in the design and provide expert recommendation regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
• May provide working coordination and feedback to others
• Performs day-to-day operational duties such as: monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.
• Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. May conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.
• Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies; developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.
• Performs other duties as assigned.

Education: Bachelor's degree in a scientific field of study related to the research of the clinical setting.

Experience: Three (3) years clinical research including two (2) years in the relevant research specialization.

Supervisory Experience: N/A

Certification/Licensure: N/A

Other: May consider a combination of directly related experience and education

Knowledge, Skills, 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: $64,000 - $72,000 (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.