Clinical Research Manager - Hematology and Oncology

University of Chicago•Chicago, IL

1d•$90,000 - $130,000•Onsite

About The Position

The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials, including sponsored, grant funded, multi-site, and/or investigator-initiated trials, in the Section of Hematology/Oncology in the Department of Medicine. The Clinical Research Manager will act as a liaison between clinical sites, the Clinical Trials Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol and applicable institutional and regulatory guidelines. Provide day to day project oversight and management to the Clinical Research Coordinators.

Requirements

College or university degree in related field.
7+ years of work experience in a related job discipline.

Nice To Haves

Master's degree.
Supervisory skills.
Background in a leadership role.
Research certification, such as Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP.
Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy, such as site monitoring, quality assurance, and creating monitoring plans.
Working knowledge of managing research projects.
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.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Develop a program and a team.
Excellent time management skills and work independently.
Strong analytical skills.
Identify funding sources.

Responsibilities

Directs 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 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 organizations’ 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.