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Clinical Research Manager

Job description



Hyde Park Campus

Department
2012217 Medicine-Hem/Onc

About the Unit
The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Information

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 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 and Data Managers on the team.

Responsibilities:

Research Conduct/Study Management:

  • 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 senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area.
  • Prepares grant/funding applications.
  • Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).


Data Management:
  • Oversees 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:
  • Ensures 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:
  • Supervises both researchers and research support staff.

Competencies:
  • Ability to develop a program and a team required.
  • Excellent time management skills and ability to work independently required.
  • Ability to develop research program and work strategically with Principal Investigator(s) required.
  • Ability to lead robust operational and financial analysis of study(ies) and/or program performance required.
  • Ability to read and understand clinical trials protocols required.
  • Knowledge of regulatory policies and procedures required.
  • Strong analytical skills required.
  • Knowledge of grant and contract administration required.
  • Familiarity with medical and scientific terminology required.
  • Demonstrated knowledge of Good Clinical Practices (GCP) required.
  • Ability to identify funding sources preferred.


Additional Requirements

Education, Experience and Certifications:
  • Bachelor's degree required.
  • Master's degree preferred.
  • Five years of clinical research experience or research experience combined with relevant experience required.
  • One year of management (personnel, program and/or project management) required.
  • Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans) preferred.
  • Supervisory skills preferred.
  • Experience managing research projects preferred.
  • Experience in a leadership role preferred.
  • Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP) preferred.


Required Documents:
  • Resume
  • Cover Letter

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualifications

Scheduled Weekly Hours
37.5

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
Yes

Does this position require incumbent to operate a vehicle on the job?
No

Health Screen Required?
Yes

Posting Date
2018-10-02-07:00

Remove from Posting On or Before
2019-04-02-07:00

Posting Statement:

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

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Full time
JR03036

About Us
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Job No:
Posted: 12/2/2018
Application Due: 12/13/2018
Work Type:
Salary: