Clinical Research Specialist, Radiation Oncology

University of Maryland Medical System Corporation; Baltimore (MD); On-site; USD 80,000 - 120,000; Full time

Job summary

University of Maryland Medical System Corporation seeks a clinical research professional to coordinate the implementation of approved protocols and support complex trial activities under supervision. This role interfaces with investigators, regulatory bodies and sponsors to ensure compliant study conduct.

The position involves study activation preparation, data collection and analysis, plus training staff. Independent work and strong communication with stakeholders are essential in delivering

Qualifications

• Ability to understand and utilize scientific terminology in communications.
• Lead role in performing various advanced, routine, and maintenance procedures.
• Ability to conduct independent projects and serve as a consultant in technical areas.

Responsibilities

• Submit protocols for review boards and coordinate responses with regulatory bodies.
• Recruit and screen subjects for research studies.
• Prepare studies for activation and develop tools/manuals for departments.
• Perform data collection, entry, verification, analysis and reporting.
• Provide training and guidance to clinical research staff.
• Participate in study design and act as liaison with sponsors and investigators.
• Ensure Good Clinical Practices and CFR compliance.
• Maintain clinical databases and monitor participant safety and continuity of care.

Skills

Clinical Research Coordination

Regulatory Submissions

Independent work

Communication Skills

Data Entry and Verification

Education

Bachelor's degree in epidemiology, sociology, psychology, nursing or related field

Tools

Statistical Software

Spreadsheet Software

Database Software

Job description

Job Requirements

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.

Job Requirements

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

• 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
• 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.
• Represents department at research and protocol initiation meetings.

Education and Experience

• 1Bachelor’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

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

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.
• Reports adverse events and near misses to appropriate management authority.
• Identifies possible risks in processes, procedures, devices and communicates the same to those in charge.