Job Details | Clinical Research Coordinator, Cancer Center. Resurrection Medical Center, Chi

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Presence Health

Location: ChicagoIL 60631 Document ID: AB053-09DH Posted on: 2017-09-1309/13/2017 Job Type: Regular

Job Schedule:Full-time
2017-10-13
 

Clinical Research Coordinator, Cancer Center. Resurrection Medical Center, Chi


Requisition ID: 27020

Location: Presence Resurrection Med

Location Address:
7435 West Talcott, Chicago, 117015 60631 United States (US)

Daily Hours: 8
Standard Hours: 40
Employment Status: Full-time
Employment Type: Regular
Shift: Day
FLSA: E

Coordinate and participate in a variety of clinical research studies conducted by principal investigators (physicians) including a variety of complex activities involving compilation, documentation, and analysis of clinical research data. Coordinate and perform study-specific regulatory processes across multiple studies of different therapeutic areas and phases.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Professional knowledge of a wide range of nursing concepts, principles, and practices for specialized nursing assignments in clinical research studies and with humanitarian use devices.

  • Apply research regulations to all duties. Ensure research quality by practicing in compliance with all Presence Health standards, IRB policies, and federal, state, and local regulations, including adherence to the principles of Good Clinical Practice (GCP).

  • Protect the rights of human subjects by obtaining proper informed consent and adhering to consent and protocol guidelines. Maintain a safe environment for subjects, their families, and staff through compliance with all federal, state, local, and standards and maintain strict patient confidentiality according to HIPAA regulations and applicable law.

  • Prepare and submit documents (protocols, amendments, clinical data, etc.) to sponsors, IRB, and regulatory entities in a timely manner, maintaining documents in accordance with applicable regulations and Presence Health standards. Assist investigators and Director of Clinical Research Operations develop plans for research projects. Collaborate on the preparation of manuscripts for publication, including assistance with study design, preparation for IRB submission, study implementation, data analysis and publication (internal or external).

  • Submit Serious Adverse Event reports (SAEs/SUAs/SAERs, etc.) and protocol deviations to the Director of Clinical Research Operations, IRB, sponsors, and other regulatory entities as appropriate per FDA regulations and guidelines.

    This document represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. Other duties may be assigned.

    QUALIFICATIONS

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    > Excellent interpersonal skills (written and verbal)

    > Ability to communicate effectively and professionally with a wide variety of individuals

    > Meet deadlines

    > Strong attention to detail

    > Highly organized

    > Abstract thinking skills

    > Team player; work collaboratively with diverse groups internal and external to Presence Health

    > Must be willing to be on call and work weekends when necessary

    Education and/or Experience

    • Bachelor's degree in business, or related field required
    • RN/Bachelor in nursing preferred
    • Master's level education preferred
    • 3 years experience working with regulatory and legal matters concerning clinical research and clinical trials preferred.
    • 3 years experience working with study documents and trial applications preferred.
    • 2 years experience gathering and preparing preliminary research information for writing teams (i.e. regulatory reports, study reports, safety narratives, etc.) preferred; provide some preliminary technical report writing.

      Computer Skills

    • Proficient in Microsoft Office (especially Word and Excel)
    • Proficient with Outlook
    • Ability to obtain data, enter it into a database, correct and clean the data, assist with data accuracy verify action, and conduct preliminary analysis of data

      Certificates, Licenses, Registrations


    Business Unit: Presence Resurrection Med Cntr
    Department Name: Cancer Center Admin RMC
         
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