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).
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. Â
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 organizationsâ™ 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. Â
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.
Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Experience managing research projects.
Experience in a leadership role.
Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP).
Ability to develop a program and a team.
Excellent time management skills and ability to work independently.
Ability to develop research program and work strategically with Principal Investigator(s).
Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
Ability to read and understand clinical trials protocols.
Knowledge of regulatory policies and procedures.
Strong analytical skills.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Ability to identify funding sources.
Cover Letter (required)
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Internal Number: JR09577
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.