Specialist, Clinical Research_

Baltimore

*The University of Maryland School of Medicine’s Institute for Clinical and Translational Research (ICTR)*is currently recruiting for a*Clinical Research Specialist*. This position is responsible for overseeing and coordinating the department's day-to-day operations of clinical research studies. *Project Overview:* My Healthy Maryland Precision Medicine Research is a long-term study developed by the University of Maryland School of Medicine’s Institute for Clinical and Translational Research. This project aims to create a resource representative of the diversity of Maryland to advance a broad range of health-related research, from understanding the genetic and molecular basis of rare and common health conditions to improving the value and efficiency of our healthcare system. *Benefits: Exempt Regular * UMB offers acomprehensive benefits packagethat 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 PAID leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, 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). *Primary Duties:* * Performs as a single specialist in a clinical setting 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 develops protocol manuals and data collection instruments. This position significantly contributes to the conduct of research. * Coordinates the preparation of the 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. May obtain tissue and blood samples as necessary and collect information through interviews, questionnaires, test results, and charts. * Significant effort will be spent on planning, organizing, and implementing in-person participant recruitment and engagement efforts. This may include recruitment and engagement events at various UMMS locations, other hospital systems, and/or community locations within the state of Maryland. * Establishes and maintains database files and reports using computer applications like Microsoft Excel/Access. * Performs data checks, audits, and data cleaning. Checks data validity and accuracy, 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. Data collection instruments such as survey questionnaires may be developed. * Maintains communication with participants and colleagues regarding protocol-specific information and research orders. Provides assessments and ensures protocol compliance while participants are in a study. * Serve 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 daily clinical research operations, study initiation, execution, and completion. Assists in the design and provided expert recommendations regarding research studies. Oversees interaction with subject participants, including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining a patient's medical history. * May provide working coordination and feedback to others. * Performs day-to-day operational duties such as ensuring quality control and safety compliance, submitting invoicing, developing policies and procedures, and ordering supplies. * Searches relevant literature, develops conclusions on research findings, writes reports, prepares and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. * May conduct library research and contribute 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 of clinical research including two (2) years in the relevant research specialization. *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 appropriate technology/systems. Ability to effectively communicate 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: $60,000 - $74,000 (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 [email protected]. 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 aUMB Job Applicant Accommodation Request. You may also [email protected]. 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* **Organization:** **School of Medicine - Centers/Programs/ORCs* **Title:** *Specialist, Clinical Research* **Location:** *null* **Requisition ID:** *240000XK*