The University of Maryland, Baltimore (UMB), Institute of Human Virology (IHV) is currently recruiting for a Clinical Research Specialist . The Clinical Research Specialist functions 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.
Manages federal and pharmaceutical industry funded clinical research trials.
Preparation of study documents including: Source documents, SOPs, CRFs, AE reports, IRB documents, regulatory documentation.
Develops, prepares, and maintains an accurate encoding of source documents. Leads in data entry and data related tasks of assigned studies. Monitor participant study treatment compliance. Coordinate site initiation and monitoring visits. Perform study procedures such as vitals, labs and ECGs and grade lab results
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Performs and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research. Develop protocol manuals and data collection instruments. Participate in the design of research studies.
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.
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.
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.
Assists in 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. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.
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.
Performs administrative duties such as providing training and guidance to students and other clinical staff, attending research meetings, and providing key information or data for the use of contract negotiation or budgeting.
May perform the tasks of the Clinical Research Assistant where applicable.
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.
Other: May consider a combination of directly related experience and education
Knowledge in the use of clinical and research electronic data base such as EPIC and RedCap is highly preferred.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday - Friday, 8:30am - 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
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 - Institute of Human Virology
Job Posting: Dec 9, 2019
Unposting Date: Ongoing
Internal Number: 140681
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.