Clin Trials Rsrch Asst/Data Mg - ICTS Coordinator Core

The Institute for Clinical and Translational Science (ICTS) is seeking a Clinical Trial Research Assistant/Data Manager to join the ICTS Coordinator Core as an integral member of our research team. This position provides essential research support by performing activities critical to advancing the ICTS research mission, strengthening research infrastructure, and fostering innovation through collaborative research support. The successful candidate will apply clinical and research skills to administer, coordinate, deliver, and evaluate clinical research protocols while supporting investigators and study teams across a portfolio of clinical trials.

Duties to include but not limited to:

Research/ Clinical Activities; Subject Recruitment and Enrollment

·       Perform clinical/health care research activities in various departments

·       Screen, recruit, enroll and obtain informed consent for clinical research activities

·       Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.

·       Relay information to principal investigator and verify patient eligibility.

·       Administer study treatments and report adverse reactions.

·       Oversee the recruitment of subjects and scheduling of trial-related procedures.

·       Prepare study recruitment materials.

Protocol Development/ Management and Study Responsibilities

·       Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.

·       Assist patients with problems related to protocol.

·       Oversee CRF development and database development and maintenance.

·       Review query reports. Resolve all monitoring visit issues.

·       Perform and monitor randomizations.

·       Develop complex study materials.

·       Serve as liaison to local health care practitioners, agencies, and sponsors.

Data Collection and Monitoring

·       Participate in the design; development and testing of clinical research trial data systems.

·       Acts as a liaison between health care clinical information systems and research data systems.

·       Validate data and make recommendations for resolution.

Regulatory Guidelines and Documents

·       Manage and organize regulatory documentation.

·       Prepare regulatory submissions.

·       Perform on-site audits of research and clinical data.

·       Monitor compliance of regulatory guidelines and proper maintenance of documents.