The Institute of Human Virology (IHV) at the University of Maryland, Baltimore (UMB) is currently seeking a Clinical Research Specialist . The Clinical Research Specialist will coordinate and implement clinical research activities for the DC Partnership for HIV/AIDS Progress (DC PFAP) Hepatitis Clinical Research Program that is part of the Clinical Research Unit at the Institute of Human Virology. This position is based in Baltimore to support the clinical research activities of the DC PFAP Program that are on-going in Baltimore. This person will be responsible for study coordination of research studies specifically investigational drug studies, overseeing staff implementation of research at sites, administrative coordination for study implementation, ongoing monitoring, and assisting with regulatory reporting. This person will work in tandem with the pharmacist, regulatory staff, other support staff, nurses and physicians also working in the DC PFAP Program and the CRU.
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.
Perform study coordinator responsibilities with regards to study-start up, implementation, monitoring and close out including IRB submission, regulatory reporting etc.
Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
Perform Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.
Serves as liaison to other departments, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
Completes case report forms and other records documenting activities such as treatments and medications received. Compiles and presents statistics of study progress internally and to sponsoring agency.
Reviews medical records and extracts, enters and updates information into an automated data file system. Keeps primary provider informed on patient enrollment.
Perform administrative duties such as providing training and guidance to students and other clinical staff, attending research meetings, and assisting with contract negotiations.
Performs other duties as assigned.
Education: Bachelors in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic.
Experience: Three (3) years clinical research including two (2) years in the relevant research specialization.
Licensure/Certification: SOCRA or CCRP certification, preferred.
Other: May consider a combination of directly related experience and education.
Knowledge, Skills, and Abilities:
Maintains thorough knowledge of protocols, nursing procedures and regulatory requirements.
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: May 15, 2019
Unposting Date: Jun 14, 2019, 3:59:00 AM
Internal Number: 123621
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.