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Job Description

Location: Chicago, IL

Hospital: RUSH University Medical Center

Department: Pediatrics-Res Adm

Work Type: Full Time (Total FTE between 0.9 and 1.0)

Shift: Shift 1

Work Schedule: 8 Hr (8:00:00 AM - 5:00:00 PM)

Summary:

This position handles the more complex clinical research studies conducted by PI(s) which may include grant-funded, industry sponsored, and investigator-initiated clinical research studies. Partners with the PI to manage multiple complex clinical research studies. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Responsibilities:

• Coordinates all aspects of complex studies, including recruitment, consent, screening, scheduling, and tracking and provides study updates to study participants throughout the conduct of the study.

• Ensures data is entered into the study’s electronic data capture system and queries are responded to and resolved in a timely manner.

• Oversees the submission of study related documents, study protocols and study protocol amendments to the IRB per policy and procedure.

• Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.

• Oversees the collection, processing and shipment of potentially biohazardous specimens.

• Oversees the administration of structured tests and questionnaires according to research study protocols including the utilization of study-related technology and equipment as part of assessment procedures.

• Reviews and finalizes summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance and ensures accurate study updates are provided throughout the conduct of the study.

• Lead the development of any required action plans in conjunction with researcher.

• Ensure unanticipated problems (protocol deviations, adverse events, and serious adverse events) are submitted in a timely manner.

• Provide recommendations to proactively address complex issues and/or variances with study related activities.

• Train and mentor clinical research staff members within the department.

• May summarize and share relevant research during internal and external presentations.

• Maintains current knowledge of industry trends.

Other information:

Required Job Qualifications:

• Bachelor's degree and 5 years of clinical research experience OR 9 years of clinical research experience.

• 5 years coordinating Human Subjects research.

• Demonstrated advanced knowledge of Good Clinical Practices and Good Documentation Practices.

• Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.

• Relevant certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professionals (CIP).

• Strong project management skills.

• Demonstrated problem-solving, critical decision makings and professional judgement.

• Strong analytical and organizational skills with a high attention to details.

• Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and vendors.

• Strong verbal and written communication with ability to communicate complex concepts to multiple audiences.

• Demonstrated ability to collaborate within multi-disciplinary team settings.

• Travel may be required.

Preferred Job Qualifications:

• Bachelor's degree in science or health related field.

• Master’s degree with science or health related field.

• Prior supervisory 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.

Position Sr Clinical Research Coordinator

Location US:IL:Chicago

Req ID 3469