Responsible for the direction of a program or research office.
Conducts research in area of expertise.
Collaborates with other researchers on long-range plans for research projects.
Oversees the development of research projects.
Ensures research projects progress according to plan.
Investigates, modifies and applies new procedures, techniques or applications of technology.
Establishes goals and operating procedures, practices, and guidelines.
Establishes, monitors, and controls project budgets.
In collaboration with research faculty and personnel, participates as a skilled individual contributor and/or researcher.
Prepares grant/funding applications.
Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).
Oversees activities related to data collection and analysis.
Coordinates 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.
Protects patients and data confidentiality by ensuring security of research data and personal health information.
Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Understands 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.
Understands the federal research regulations and identifies the federal research organizationsâ™ role in regulating human research participation.
Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Supervises 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.
Proficient monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Working knowledge managing research projects.
Background in a leadership role.
Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP). Â
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 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).
Identify funding sources. Â
Cover Letter (required)
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Internal Number: JR10375
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.