Clinical Research Director jobs in Illinois

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Clinical Research Coordinator III
  • DM Clinical Research
  • Chicago, IL FULL_TIME
  • Clinical Research Coordinator III

    A CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.


    DUTIES & RESPONSIBILITIES
    • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
    • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
    • Sponsor-provided and IRB-approved Protocol Training
    • All relevant Protocol Amendments Training
    • Any study-specific Manuals Training, as applicable
    • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
    • Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
    • Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
    • Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
    • Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
    • Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
    • Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
    • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
    • Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
    • Ability to train and mentor site staff, as needed
    • Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
    • Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
    • Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
    • Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
    • Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
    • Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
    • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
    • Being prepared for and available at all required company meetings.
    • Submitting required administrative paperwork per company timelines.
    • Occasionally attending out-of-town Investigator Meetings
    • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
    • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
    • Facilitate effective communication between patients, healthcare providers, and research staff
    • Any other matters as assigned by management

    KNOWLEDGE & EXPERIENCE

    Education:
    • High School Diploma or equivalent required
    • Bachelor's degree preferred
    • Foreign Medical Graduates preferred
    Experience:
    • Minimum of 5 years experience in Clinical Research
    • Supervisory experience preferred
    • Wide therapeutic range of clinical trials experience preferred
    • Regulatory research experience is a plus
    Credentials:
    • ACRP or equivalent certification is preferred
    Knowledge and Skills:
    • Goals-driven while continuously maintaining quality.
    • Must be detailed-oriented, proactive, and able to take initiative.
    • Must have strong written and communication skills.
    • Must have excellent customer service skills.
    • Proficient communication and comprehension skills both verbal and written in the English language are required.
    • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
  • 2 Months Ago

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Senior Director, Clinical Research
  • Tempus
  • Chicago, IL FULL_TIME
  • Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way...
  • 1 Month Ago

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Director, Clinical Research - Surgery
  • uic
  • Chicago, IL FULL_TIME
  • Position SummaryThe Director of Clinical Research provides oversight to the Clinical Research Team housed in the Department of Surgery. This position is responsible for overseeing all aspects of study...
  • 16 Days Ago

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Clinical Research Physician
  • GenHarp Clinical Solutions
  • Evergreen, IL FULL_TIME
  • The Clinical Research Physician (Principal Investigator) role will be based in Evergreen Park, IL, and is a part-time contract position. This role is hybrid (remote and on-site). Job Duties & Responsi...
  • 10 Days Ago

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Senior Clinical Research Associate
  • OnPoint Clinical Staffing Services
  • Chicago, IL FULL_TIME
  • Job DescriptionSenior CRAResponsibilities include:* All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical t...
  • 20 Days Ago

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Clinical Research Coordinator
  • Revival Research Institute, LLC
  • Elgin, IL FULL_TIME
  • Unique opportunity to make an Impact in the healthcare industry…Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since....
  • 2 Days Ago

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Senior Clinical Research Director
  • Sanofi Group
  • Cambridge, MA
  • **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
  • 6/11/2024 12:00:00 AM

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Clinical Research Director I&I
  • Sanofi Group
  • Cambridge, MA
  • **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
  • 6/11/2024 12:00:00 AM

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Clinical Research Director, I&I
  • Sanofi Group
  • Cambridge, MA
  • **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
  • 6/11/2024 12:00:00 AM

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Director of Clinical Research Consulting
  • Vitalief Inc.
  • New Brunswick, NJ
  • WHY VITALIEF? Vitalief is an innovative Healthcare consulting company, focused on empowering Research and transforming C...
  • 6/10/2024 12:00:00 AM

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Principal Clinical Research Director, I&I
  • Sanofi Group
  • Cambridge, MA
  • **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
  • 6/9/2024 12:00:00 AM

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Sr. Director, Procurement - Clinical Research Group
  • Thermo Fisher Scientific
  • Morrisville, NC
  • Job Description About Thermo Fisher Scientific: When you're part of the team at Thermo Fisher Scientific, you'll do mean...
  • 6/9/2024 12:00:00 AM

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Clinical Research Director - 219072
  • Medix™
  • Franklin, TN
  • Role The Clinical Research Director (CRD) is a specialized research professional working with and under the direction of...
  • 6/8/2024 12:00:00 AM

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Director of Clinical Research
  • Eastern Connecticut Hematology & Oncology
  • Norwich, CT
  • Director of Clinical Research Opportunity Eastern Connecticut Hematology & Oncology Norwich, CT Job Details: Occupation:...
  • 6/7/2024 12:00:00 AM

Illinois (/ˌɪlɪˈnɔɪ/ (listen) IL-ih-NOY) is a state in the Midwestern and Great Lakes region of the United States. It has the fifth largest gross domestic product (GDP), the sixth largest population, and the 25th largest land area of all U.S. states. Illinois is often noted as a microcosm of the entire United States. With Chicago in northeastern Illinois, small industrial cities and immense agricultural productivity in the north and center of the state, and natural resources such as coal, timber, and petroleum in the south, Illinois has a diverse economic base, and is a major transportation hu...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$146,903 to $198,310

Clinical Research Director in Racine, WI
For those interested in the field or already working in clinical research, here are five reasons why it makes for a brilliant career.
January 02, 2020
Clinical Research Director in Winston Salem, NC
In order to address the complex medical and dental issues facing the US and international community, a trained clinical research workforce is critical to ensure that research is aligned with the highest scientific, ethical, and regulatory standards.
February 03, 2020
Clinical Research Director in Saint Louis, MO
At UHealth, our dedicated physicians and MSOM researchers offer patients the shortest distance between breakthrough and treatment.
February 09, 2020
Specific to the clinical trials piece, biopharma’s dynamic pipelines and significant cash resources has them in search of people to move their programs along.
January 08, 2020