Lead Clinical Research Coordinator - Stem cell - Congenital Heart Disease

Job Locations US-IL-Chicago
Posted Date 1 month ago(4/1/2021 4:43 PM)
Requisition ID
2020-14413
Category
Research
Position Type
Regular Full-Time
Shift
Days

Overview

The Lead Clinical Research Coordinator works with PI, but functions independently; responsible for the complete coordinator of assigned clinical research activities. May have supervisory responsibilities of study staff.

 

This is your opportunity to use all of your skills within a transformative environment and be part of a
world-class team. In this vital role, you will work closely with accomplished faculty who are highly
motivated to advance research for children with congenital heart disease. The Heart Center features a
broad portfolio of open studies, including investigator-initiated studies and multicenter group studies,
as well as industry sponsors. You will have the opportunity to lead subject recruitment, regulatory
and data responsibilities for our center and assist in the guidance of other centers.

 

Please visit our Heart Center Research page to learn more about clinical research in Cardiology https://www.luriechildrens.org/en/specialties-conditions/heart-center/research/

 

Responsibilities

  1. Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.
  2. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
  3. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.
  4. Identifies and recruits eligible study subjects; conducts informed consent/assent process.
  5. Conducts site qualifications, study initiation, monitoring and/or close-out visits.
  6. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis.
  7. Creates and/or updates case report forms and/or source document templates.
  8. Coordinates multiple and/or more complex clinical research protocols.
  9. Assists in the preparation of budgets and fund management.
  10. Assists in the conduct of statistical analysis.
  11. Functions as a mentor/resource to other CRPs.
  12. Building codebooks for data dictionaries.
  13. Prepares and negotiates budgets with sponsors; Provides oversight of study charges to fund accounts and ensures timely and accurate invoicing.
  14. Leads the development, implementation and evaluation of multiple or complex clinical research studies.
  15. Performs independent statistical analysis of clinical research data at a basic level or works with study statistician on analysis (SPSS, SAS, Stata)
  16. Prepares manuscripts for publication and other presentations, as applicable.
  17. Other job functions as assigned.

Qualifications

1. Bachelors with five to seven years clinical research experience.

2. Prior leadership experience preferred.

3. Strong analytical and organizational skills. Strong customer service skills.

4. Strong verbal and written communication skills in order to address diverse/large audiences.

5. Must be assigned to a status of 0.5 fTE or higher.

6. Demonstrated working knowledge of regulatory practices required.

7. Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) required.

8. Proficient in using advanced Excel formulas like VLOOKUP and COUNTIF/IF

9. Proficient in using pivot tables.

10. Emergency Medicine experience a plus.

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