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Associate Clinical Research Coordinator
4 months ago
Hospital: RUSH University Medical Center
Department: Res-Recr - Mokhlesi
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (9:00:00 AM - 5:00:00 PM)
Summary:
This position works under the general direction of the Lung Center, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP) S/he will coordinate standard clinical research studies conducted by PI(s) which may include grant-funded, industry sponsored, and investigator-initiated clinical research studies. S/he will perform a variety of routine duties involving the collection, compilation, and documentation of clinical research data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Responsibilities:
• Recruits, consents, screens, schedules, tracks and provides study updates to study participants throughout the conduct of the study.
• Collects and enters data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
• May submit or coordinate the submission of study related documents, study protocols and study protocol amendments to the IRB per policy and procedure
• Maintains accurate and complete procedural documentation including study participant and site level documentation in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.
• May collect, process and ship potentially biohazardous specimens.
• Administers structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures.
• Provide ongoing study status updates and responds to questions from PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study
• Organize and participate in auditing and monitoring visits
• Gather and communicate unanticipated problems (protocol deviations, adverse events, and serious adverse events).
• Work with PI(s), sponsor, compliance, clinical staff and/or manager to identify and improve routine processes as it relates to the conduct of the research study
Required Job Qualifications:
• Bachelor's degree and 1 year of clinical research experience OR 5 years of clinical research experience.
• Demonstrated knowledge of Good Clinical Practices and Good Documentation Practices.
• Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
• Ability to meet deadlines and help coordinate multiple aspects of the ongoing project.
• Strong organizational and problem-solving skills.
• Detail oriented with high attention to accuracy.
• Ability to build rapport, navigates sensitive topics, and maintains confidentiality with a diverse pool of research participants and vendors.
• Effective verbal and written communication skills.
• Ability to collaborate within multi-disciplinary team settings.
• Availability to work evenings, overnight and weekends if called for under the study protocols.
• Travel may be required.
Preferred Job Qualifications:
• Bachelor's degree in Sciences or health-related discipline.
• Prior participant contact experience.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
