Clinical Research Coordinator II - Radiation Oncology

Job Requirements

Responsibilities

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. 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. Prepares documents for initiation meetings and leads discussions.

Work Experience Education and Experience Bachelor’s degree in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic is required. Four (4) years of experience in clinical research is required. Education may substitute for lack of requisite experience. 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 research 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. Knowledge of oncology research preferred

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.