Clinical Research Director jobs in Orland Park, IL

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.
  • 7 Days Ago

A
Clinical Research Associate
  • Advanced Clinical
  • Chicago, IL FULL_TIME
  • OVERVIEWWe are currently searching for a skilled professional to join a well-known client's team as a remote Clinical Research Associate. The CRA is responsible for the management of day-to-day aspect...
  • 2 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...
  • Just Posted

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Clinical Research Coordinator (CRC)
  • Center for Clinical and Translational Science
  • Chicago, IL FULL_TIME
  • Clinical Research Coordinator, UIC Center for Clinical and Translational ScienceThe Clinical Research Coordinator works within the CCTS Clinical Research Center and is responsible for managing and coo...
  • 19 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...
  • 2 Months Ago

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Senior Clinical Research Associate (West Coast - Oncology)
  • Advanced Clinical
  • Deerfield, IL FULL_TIME
  • ***This position can work remotely anywhere in the United States*** What's in it for YOU? Competitive compensation with comprehensive medical, vision, and dental benefits package 10 paid holidays incl...
  • 2 Months Ago

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0 Clinical Research Director jobs found in Orland Park, IL area

Orland Park is a village in Cook County, Illinois, United States, a suburb of Chicago, which in 2010 had a population of 56,767. 25 miles (40 km) southwest of Chicago, Orland Park is close to several interstate highways, with the I-80 east-west coast connector as its southern border. The Metra commuter rail system links it to the Chicago Loop and from there to O'Hare and Midway airports. According to the 2015 census, Orland Park has a total area of 22.167 square miles (57.41 km2), of which 21.88 square miles (56.67 km2) (or 98.71%) is land and 0.287 square miles (0.74 km2) (or 1.29%) is water....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$146,228 to $197,401
Orland Park, Illinois area prices
were up 0.8% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020