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BSD MED - Cardiology - Administration

About the Department

The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago.

Job Summary

The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials (sponsored, grant funded, multi-site, and/or investigator-initiated trials) in the Section of Cardiology in the Department of Medicine.

Responsibilities

Research Conduct/Study Management:

• Responsible for the direction of a program or research office.
• Conduct research in area of expertise.
• Collaborate with other researchers on long-range plans for research projects.
• Oversee the development of research projects.
• Ensure research projects progress according to plan.
• Investigate, modify and apply new procedures, techniques or applications of technology.
• Establish goals and operating procedures, practices, and guidelines.
• Establish, monitor, and control project budgets.
• In collaboration with research faculty and personnel, participate as skilled individual contributor and/or researcher.
• Prepare grant/funding applications.
• Manage financial, personnel, planning, compliance and other administrative aspects of research project(s).

Data Management:

• Oversee activities related to data collection and analysis.
• Coordinate the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Protect patients and data confidentiality by ensuring security of research data and personal health information.

Regulatory:

• Ensure compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
• Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
• Understand the federal research regulations and identify the federal research organizations\' role in regulating human research participation.
• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

Supervision:

• Supervise both researchers and research support staff.

• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.

• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

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Certifications:

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Prefer ed Qualifications

Education:

• Master\'s degree.

Experience:

• Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
• Supervisory skills.
• Working knowledge of managing research projects.
• Background in a leadership role.

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP).

Preferred Competencies

Develop a program and a team.

Excellent time management skills and ability to work independently.

Develop research program and work strategically with Principal Investigator(s).

Lead robust operational and financial analysis of study(ies) and/or program performance.

Read and understand clinical tr