Clinical Research Specialist

at  University of Maryland Baltimore

The University of Maryland, Baltimore Department of Neurosurgery is seeking a Clinical Research Specialist. The incumbent in this position is a member of the Department of Neurosurgery Clinical Research Team and provides essential support to clinical research activities by coordinating care, quality control, and data management.

The department aims to excel and innovate in the clinical practice, science, and education of neurosurgery. We seek to achieve this by creating a platform and culture whereby all team members contribute to this mission and reach their full capacity for impact and fulfillment. Critical to our success is each team member’s alignment and demonstration of our shared values:

• Patients First
• Always Do the Right Thing
• Leave It Better Than You Found It
• Drive at Mastery

MINIMUM QUALIFICATIONS

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: $61,000 - $67,000 per year (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.
Job: Reg or CII Exempt Staff - E3304E
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: School of Medicine - Neurosurgery
Job Posting: Apr 4, 2024
Unposting Date: Apr 12, 2024, 10:59:00 P

SCOPE OF ROLE

Accomplishes responsibilities by applying specialized and theoretical knowledge, principles, and concepts of a professional discipline normally acquired through advanced education or specialized training. Resolves issues and significant matters on behalf of management by utilizing independent judgment, discretion, creativity, and analytical thinking. Contributes to development and evaluation of goals and objectives. Creates solutions to ensure legal and policy compliance. May supervise, mentor, or coordinate work of others (positions that supervise are responsible for service delivery, quality assurance, and employee performance). May independently manage or administer programs, processes, projects, or resources.
Applies in-depth, senior level knowledge, concepts, principles, and skills. Wide latitude in decision making to interpret unclear or inadequate guidelines. Supervisor and employee collaborate to develop goals and objectives. Confers with supervisor only on controversial or far reaching matters. Proactively resolves broad and unique matters requiring sophisticated analysis and interpretation. Acts as a resource to others.

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. This 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.
  Qualifications