100% Clinical Trial & Data Management Research Associate - Emergency Medicine

The Clinical Trial & Data Management Research Associate role in Emergency Medicine (EM) will be an integral member of the research team. This position will provide support for Emergency Medicine working alongside the ICTS team performing activities which are vitally important to grow and foster innovation through research support endeavors. This position will apply clinical skills to administer, deliver, and evaluate research protocols.

Research/Clinical Activities, Subject Recruitment and Enrollment

• Screen participant for study eligibility.
• Educate participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for participant.
• Communicate with principal investigator and verify participant eligibility.
• Administer study treatments and identify adverse reactions.
• Recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
• Prepare study recruitment materials. Develop complex study recruitment materials.

Protocol Development/Management and Study Responsibilities

• Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assess participants for problems related to protocol. Oversee CRF development, database development and maintenance.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials used in conduction of study.
• Communicate with local health care practitioners, agencies, and sponsors as needed.

Data Collection and Monitoring

• Participate in the design, development, and testing of clinical research trial data systems.
• Maintain communication between health care clinical information systems and research data systems.
• Collect and validate data. Make recommendations for query resolution.
• Assist with identification of data problems and implement change as needed.

Regulatory Guidelines and Documents

• Manage and organize regulatory documentation.
• Prepare and submit regulatory documents.
• Assist sponsor with on-site audits of research and clinical data.
• Monitor and maintain compliance of regulatory guidelines and documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• Carry out corrective action plan for reportable events.

Financial Responsibility

• Assist in the development and administer study budgets.
• Participate in preparation of grant applications for extramural funding.
• Oversee internal pilot funding program application process.
• Assist with tracking and reconciling grant budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.