The Department of Pediatrics in the University of Maryland, Baltimore School of Medicine is hiring for a Lead Clinical Research Specialist for the Division of Growth and Nutrition. This position functions as the lead in a clinical setting who is responsible for providing the highest technical expertise and guidance to research programs, projects, and activities. This position is responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a variety of complex activities. This position is also responsible for networking with faculty and staff to achieve strategic goals and maximize efficiency.
The Lead Clinical Research Specialist will support the research of the Division of Growth and Nutrition. The Division seeks to nurture children's growth and development through research and practice by conducting research in collaboration with community organizations to promote children's healthy growth and development. The Division coordinates a multidisciplinary Growth and Nutrition Practice for children with growth and/or feeding problems.
This is an exempt, regular position and offers a generous benefits package that includes 22 vacation days, 14 floating and observed 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.
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 trials.
Trains and provides mentoring to other research personnel in the submission of research protocols, IRB submissions, research procedures and policies, etc. Serves as subject matter expert and provides guidance on regulatory matters and compliance for staff, faculty, and leadership.
Oversees day to day clinical research operations and leads study initiation, execution, and completion. Leads the design of 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.
Lead 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. Develops individualized monitoring plans and monitoring and 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.
Searches relevant literature, develops conclusions, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experience members of the research team.
Develop, recommend, modify and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Perform Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.
Perform 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.
Performs other duties as assigned.
Education: Bachelors in Epidemiology, Sociology, Psychology, Nursing or 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: Consideration may be given for a unique combination of education and experience.
Hiring Range: Commensurate with education and experience.
If accommodations are needed, contact Human Resource 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 - E3324F
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Organization: School of Medicine - Pediatrics
Job Posting: Jun 12, 2019
Unposting Date: Jul 3, 2019, 3:59:00 AM
Internal Number: 126181
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.