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https://illinoisjoblink.illinois.gov/jobs/11863087 Department
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:
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