Shoulder Elbow Research Coordinator - RUSH Chicago

5 years 5 months ago - 5 years 5 months ago #34034 by romeo.research
General Summary of Position Responsibility:

This position is located in Chicago, IL at Midwest Orthopaedics at RUSH for Dr. Anthony Romeo. The Research Coordinator’s general role is to assist with the administration of a clinical study regarding shoulder implants and overseeing several databases of information regarding shoulder health and function; therefore, an in-depth knowledge of orthopedics, specifically the shoulder, and related medical terminology is strongly preferred. He/She will also be responsible for collecting and managing patient and laboratory data for clinical research projects, screening and overseeing the recruitment of subjects, and arranging study visits and providing instructions to participants/families. He/she will be responsible for overseeing data auditing and quality assurance practices of the various research databases, and other related tasks as needed. The Research Coordinator will be responsible for following IRB, HIPAA and Human Subjects protection policies to ensure ethical research practices and maintenance of patient confidentiality in a multicenter research setting. On-the-job training will be provided as necessary. This is a full-time position and is benefits eligible.

Essential Job Functions:

Clinical Research Studies
- Arranges study visits and provides instructions related to research study.
- Assists in creating and updating case report forms and/or source documents.
- Abstracts data from medical records and enters medical information/data onto protocol specific case reports forms, study flow sheets and other required study forms.
- Participates in the identification of eligible research subjects.
- Creates and performs QA/QC procedures, orders supplies for data collection, develops worksheets/tools for collecting patient data and enters data electronically via web based systems.
- Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and sponsor.
- Prepares abstracted/coded data for computer processing/analysis. Attends investigator meetings.
- Maintains investigator/sponsor files in accordance with FDA and Good Clinical Practice (GCP) Guidelines.

Database Studies
- Maintains retrospective databases of patients who’ve undergone various surgical or medical procedures.
- Prospectively recruit patients into various clinical studies regarding shoulder health and function.
- Independently interpret physician notes, laboratory reports, and medical imaging for the collection of research data.
- Ability to analyze large datasets in order to identify patterns or other pertinent research data
- Independently critique study proposals and identify conflicts, obstacles or other issues that may delay or prevent successful completion of the study.
- Knowledge and understanding of the informed consent process for prospective research studies involving human subjects.
- Assist in training study coordinators to ensure full compliance with study protocol
- Ensure all research team members comply with IRB and HIPPA requirements.
- Systematically maintain and organize paper and electronic research study documents.
- Assist with the submission of research abstracts and related material to professional meetings.
- Assist with developing presentation materials, meeting agendas and annual reports as needed.
- Demonstrate initiative, good judgment, organization and attention to detail.
- Independently manage work schedule to best utilize time and skills without direction from others.
- Recognize and perform unassigned duties as needed.
- Regularly assist and/or train others as need is perceived.
- Adhere to a high level of work quality with a minimum need for review or revision.

Knowledge, Skills and Abilities:
- Bachelor‘s degree in health science related field required. Master’s degree preferred.
- Minimum of 2 years of experience in a orthopedic, shoulder, medical device or similar research or healthcare environment preferred.
- Current professional licensure (if applicable).
- Working knowledge of all applicable research regulations (FDA, GCP, etc.)
- Good Clinical Practices documentation required as necessary.
- Familiarity and experience with FDA and IRB regulatory requirements is preferred.
- Strong organizational, communication, and analytical skills.
- Strong skills in various computer software including but not limited to Microsoft Office, electronic medical records systems, digital radiographic imaging systems and research databases.
- Ability to travel up to 15 miles to various clinical sites required.
- Two year commitment or more preferred

If interested please email with the following information:
1. "Orthopedic Research Coordinator" in the subject line
2. CV/resume
3. Desired salary (if negotiable please list a range)
4. Earliest starting date
Last edit: 5 years 5 months ago by romeo.research.

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