General Summary

Under general supervision, coordinates the implementation of research protocols approved for activation at the University of Maryland Medical System. Responsible for conducting daily study-related activities. Oversees the implementation of multi-site protocols as required under the guidance of staff leadership. Ability to work independently and in a team environment.

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. Interface with relevant groups, industry sponsors, patients, physicians, or other members of the health care team.
• Recruit and screen subjects for research studies. Review clinical records and communicate with study clinicians/PIs to ensure subjects are compliant with protocol eligibility criteria.
• Develop protocol manuals and data collection instruments. Make recommendations for protocol modifications to support stated research objectives, as assigned.
• Act as the lead representative for multi-site protocols in which UMMC is the coordinating center, when appropriate. Prepare and lead discussions with subsites, sponsors, and PIs. Communicate with sites to ensure proper adherence to protocols and provide guidance when necessary. Work with study leadership to maintain compliance with institutional and federal regulatory guidelines.
• Communicate with finance office to ensure payment for patient accruals and participant payments, completion of projects, and completion of milestones.
• Perform clinical research activities including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Conduct literature research and contribute 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 external study sites as appropriate.
• Participate in the design of research studies, including editing protocols for appropriate activities and institutional language.
• 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 internally and externally.
• Acts as liaison between the institution, additional participating institutions, and the study sponsor by preparing study reports and communicating with clinical study monitors. Updating PI of all internal and external activities and results.
• Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations as well as prepare protocols, consent forms, and all accompanying documents for submission to the departmental, IRB and internal/external review entities
• Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service and oversees data entry by data management staff.
• 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.

a. Communicates with the Institutional Review Board (IRB) and other departmental review committees.

b. Acts as a consultant to members of the health care team.

c. Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures.

d. Communicates treatment modifications and amendments to faculty and staff.

e. 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. Prepares documents for initiation meetings and leads discussions.