General Summary

Under general supervision, coordinates the implementation of research protocols approved for activation at the University of Maryland Medical System. Participates in complex clinical trial preparation and implementation; ability to work independently.

Principal Responsibilities and Tasks

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

• Submit protocols through appropriate review boards; assist in responding to queries; maintain proper communication with regulatory bodies Interface with relevant groups, industry sponsors, patients, physicians, or other members of the health care team.
• Recruit and screen subjects for research studies.
• Prepare studies for activation. Develop tools to assist in the proper study conduct, including cheat-sheets and manuals for various internal and external departments.
• Perform clinical research activities per approved protocol including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.
• Perform administrative duties such as providing training and guidance to other clinical research staff.
• Participate in the design of research studies
• Anticipates and carries out independent actions necessary to provide competent and professional support to meet the needs of the faculty physicians, patients, administrators, co-workers, and others involved with clinical trials. Acts as a resource to investigators, faculty physicians and clinical research coordinators.
• Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
• Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations.
• Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service; periodically reviews data for compliance.
• Oversees interaction with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms; managing continuity of care.

Assists clinical investigator with study initiation, conduction, and completion.

• Communicates with the Institutional Review Board (IRB) and other departmental review committees.
• Acts as a consultant to members of the health care team.
• Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures.
• Communicates treatment modifications and amendments to faculty and staff.
• Prepares study results for presentation and/or publication.
• Prepares and responds to audits conducted by study sponsors.
• Represents department at research and protocol initiation meetings.