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*The Institute of Human Virology (IHV)*at the*University of Maryland School of Medicine (UMSOM)*is currently recruiting for an*Open Rank Clinical Research Specialist or Lead Clinical Research Specialist*position. This position will provide study coordination for study(ies) implemented by the Research Initiative for Infectious Disease and Substance Use (RIIS). *Benefits (Exempt Regular): * UMB offers acomprehensive benefits packagethat prioritizes wellness, work/life balance, and professional development, along withadditional exciting perksthat employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) 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, 16 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). *UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland. * *Primary Duties:* *Clinical Research Specialist 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. * 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. * 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. * 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. *OR* *Lead Clinical Research Specialist Duties:* * Leads the highest technical research and guides research programs, projects, and activities in a clinical setting. * Responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a variety of complex activities. Networks with faculty and staff to achieve strategic goals and maximize efficiency. * Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for 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. * Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data in order to prepare research findings for publications of journal articles and grant proposals. * Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial. * Performs advanced 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 the management of day-to-day clinical research operations and leads 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. * Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experience members of the research team. * Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures and policies, etc. Serves as subject matter expert and provides guidance for staff, faculty, and leadership. Develops 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. *Clinical Research Specialist 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. *Other:*May consider a combination of directly related experience and education. *OR* *Lead Clinical Research Specialist Qualifications:* *Education:*Bachelor’s degree in scientific field of study related to the research of the clinic. *Experience:*Five (5) years clinical research including three (3) years in the relevant research specialization. *Other:*Master’s degree in related field may be substituted for two (2) years of related experience. *Preferred Experience:* * Knowledge of conducting research with a focus in substance use. * Strong regulatory and IRB submission experience encouraged. * Experience working with people who use drugs. *Hiring Ranges: Commensurate with education and experience * *Clinical Research Specialist: $62,895 - $73,000* ** *Lead Clinical Research Specialist: $74,000 - $85,000* UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification. 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. The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read theUMB Notice of Non-Discriminationfor more information. **Job:** **Reg or CII Exempt Staff* **Organization:** **School of Medicine - Institute of Human Virology* **Title:** *OPEN RANK Clinical Research Specialist or Lead Clinical Research Specialist * **Location:** *null* **Requisition ID:** *250000K6*