Clinical Research Specialist Jobs

Company Description

Renowned as the academic flagship of the University of Maryland Medical System, our Magnet®-designated facility is a nationally recognized, academic medical center with opportunities across the continuum of care. Come join UMMC and discover the atmosphere where talents and ideas come together to enhance patient care and advance the science of nursing. Located in downtown Baltimore near the Inner Harbor and Camden Yards, you won’t find a more vibrant place to work!

If applying from out of state, please state if you are looking to relocate.

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.

• Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations.
• Perform administrative duties such as providing training and guidance to other clinical research staff.
• Prepare studies for activation. Develop tools to assist in the proper study conduct, including cheat-sheets and manuals for various internal and external departments.
• 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.
• Recruit and screen subjects for research studies.
• Oversees interaction with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms; managing continuity of care.
• Participate in the design of research studies
• Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service; periodically reviews data for compliance.
• 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.
• Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
• 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. N

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.
• Prepares and responds to audits conducted by study sponsors.
• Communicates treatment modifications and amendments to faculty and staff.
• Represents department at research and protocol initiation meetings.
• Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures.
• Prepares study results for presentation and/or publication.

Qualifications

Education and Experience

• Bachelor’s degree in epidemiology, sociology, psychology, nursing or field of study related to the research is required.
• No experience is required.
• May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.

Knowledge, Skills And Abilities

• Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.
• Ability to network with, and present information to key groups and individuals.
• Ability to perform independent projects and to serve as a consultant in area of technical specialty.
• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to conduct library research and participate in the preparation of journal articles.
• Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.
• Knowledge of best practice in Clinical Research.
• Ability to use measurable and verifiable information for making decisions or judgments.
• Ability to take a lead role in performing and directing various advanced, routine, and maintenance procedures.
• Ability to complete and administer complex research protocols.

Patient Safety

• Ensures patient safety in the performance of job functions and through participation in hospital, department or unit patient safety initiatives.
• Takes action to correct observed risks to patient safety.
• Identifies possible risks in processes, procedures, devices and communicates the same to those in charge.
• Reports adverse events and near misses to appropriate management authority.