Entry Level Clinical Research Specialist

Company Description

The University of Maryland Medical System (UMMS) serves more than one million patients and families every year. More than 29,000 employees and 4,600 providers work at UMMS. Each and every one of these individuals – from the patients we care for, the family members we reassure to our colleagues that we champion – represent the amazingly vibrant communities we serve. And we continue to seek out qualified candidates who reflect the values, backgrounds and stories of our neighbors and patients. We want to hear your voice, learn from your experiences, and be shaped by your insight as part of our workforce. After all, when we come together from different walks of life, we become stronger, better, and more empathetic.

This position is within our Radiation Oncology department for clinical research/trials.

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.

• Oversees interaction with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms; managing continuity of care.
• 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.
• Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
• Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service; periodically reviews data for compliance.
• 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
• 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.
• 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.
• Participate in the design of research studies
• Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations.

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

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

Qualifications

Education and Experience

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

Knowledge, Skills And Abilities

• Ability to complete and administer complex research protocols.
• Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.
• Ability to take a lead role in performing and directing various advanced, routine, and maintenance procedures.
• Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.
• 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 use measurable and verifiable information for making decisions or judgments.
• Ability to network with, and present information to key groups and individuals.
• Knowledge of best practice in Clinical Research.

Patient Safety

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