Research Specialist, Clinical (Regulatory Coordinator)-(170001J3)
The University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center is seeking a Research Specialist, Clinical to serve in the capacity of a Regulatory Coordinator. The Regulatory Coordinator coordinates and manages a caseload of clinical trials for multiple oncology disease areas as it pertains to regulatory transactions (i.e. IRB submissions). This position provides guidance to the GCC Clinical Research Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards.
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.
Develops, recommends, modifies and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards.
Performs and directs studies and/or project(s) in consultation with upper management or principal investigator.
Develops protocol manuals and data collection instruments. Present research findings. Assembles and conducts library research and editing and preparing research findings for publication of journal articles and grant proposals.
Prepares new research studies, to include the informed consent, for Departmental and Institutional Review Board (IRB) review in the IRB's electronic system, with a concentration in investigator initiated trials.
Processes continuing reviews and amendments for IRB approved studies. Assists principal investigators in preparing the protocol and informed consent form for PI initiated research studies.
Serves as a consultant and provides guidance on regulatory matters for the staff, faculty and leadership.
Communicates with the Institutional Review Board (IRB) to resolve administrative modifications and address queries. Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
Prepares and responds to audits conducted by study sponsors. Represents department at research and protocol initiation meetings.
Attends and participates in various inservice and external trainings, workshops, conferences and other relevant programs for professional growth and development.
Other duties as assigned.
Education: Bachelor's degree in a scientific/medical/biological field. Experience: Three (3) years of experience in a clinical research setting, with two (2) years of specialization. License/Certification: SOCRA and/or CCRP desirable but not required.
Knowledge, Skills, and Abilities:
Knowledge of human subjects research, the regulations and policies surrounding it.
Prior experience with patients, patient interaction.
Ability to represent the Cancer Center and its faculty in a professional manner.
Ability to keep patient information confidential, knowledge of HIPPA regulations.
Strong PC skills, ability to use web-based applications and programs.
Hiring Range: Commensurate with education and experience.
If accommodations are needed, 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.
Employee Class :Exempt Regular
Full Time/Part Time:Full-Time
:Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
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, globa...l 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.