Clinical Research Coordinator

Department:
SOM KC Rehabilitation Medicine

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Segal Lab
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
Required Qualifications:

• Education: Associate degree, plus four years related work experience OR experience may substitute for degree on a year for year basis.
• Work Experience: Knowledge of FDA regulations, ICH-GCP guidelines and KUMC policies and practices.
• Skills: Excellent communication skills as evidenced by application materials and interview. Ability to work independently with moderate direct supervision. Demonstrated ability to multitask

Preferred Qualifications:

• Strong organization skills, attention to detail and time management skills.
• Microsoft Office proficiency (ie. word, excel, and power point) and computer spreadsheet management skills.
• Prior experience with independent coordination of human research projects.
• Experience in health behavior education is desirable.
• Ability to write and proofread medical research desirable.

Job Duties Outlined:

• Assist in development and implementation of research protocols. Troubleshoot and analyze protocols; propose modifications to other researchers. Ensure quality assurance for data collection protocols.
• Generation of and presentation of research finance reports on at least a monthly basis for tracking transactions and budgets for each account and project.
• Set up and operate equipment for experiments. Perform experimental procedures assuring fidelity to protocols. Record and consolidate data. Track progress/success of research project.
• Assist in formatting and submission of manuscripts and publications; collect, track and perform data entry for reports.
• Administrative coordination and submission of grant applications.
• Recruit human subjects and follow procedures for protection of human subjects in research.
• Perform a variety of routine tasks related to the monitoring of human subjects research, including working closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
• Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day- to- day study and program management. Track progress of projects and create progress reports.  Prepare research reports for research personnel and funding organizations. Ensure the data collection and research protocols follow all sponsor and institution protocols.
• Complete and maintain research training and certification. Assure research team members in area of responsibility comply with all applicable regulatory and other appropriate policies and approved practices. Responsibilities for regulatory activities include:
  • Prepare development and make submission of all regulatory documents including submission of study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. Maintain trial master file and/or regulatory binder.
  • If applicable, provide assistance to study monitors during routine monitor visits or audits
  • Maintain regulatory records throughout the life of the trial to include: submission of all study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. 
• Perform other duties as necessary.

Required Documents:

• Resume/CV
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:

Minimum

51348

Midpoint

65352

Maximum

79356

Department:
SOM KC Rehabilitation Medicine

-----

Segal Lab
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
Required Qualifications:

• Education: Associate degree, plus four years related work experience OR experience may substitute for degree on a year for year basis.
• Work Experience: Knowledge of FDA regulations, ICH-GCP guidelines and KUMC policies and practices.
• Skills: Excellent communication skills as evidenced by application materials and interview. Ability to work independently with moderate direct supervision. Demonstrated ability to multitask

Preferred Qualifications:

• Strong organization skills, attention to detail and time management skills.
• Microsoft Office proficiency (ie. word, excel, and power point) and computer spreadsheet management skills.
• Prior experience with independent coordination of human research projects.
• Experience in health behavior education is desirable.
• Ability to write and proofread medical research desirable.

Job Duties Outlined:

• Assist in development and implementation of research protocols. Troubleshoot and analyze protocols; propose modifications to other researchers. Ensure quality assurance for data collection protocols.
• Generation of and presentation of research finance reports on at least a monthly basis for tracking transactions and budgets for each account and project.
• Set up and operate equipment for experiments. Perform experimental procedures assuring fidelity to protocols. Record and consolidate data. Track progress/success of research project.
• Assist in formatting and submission of manuscripts and publications; collect, track and perform data entry for reports.
• Administrative coordination and submission of grant applications.
• Recruit human subjects and follow procedures for protection of human subjects in research.
• Perform a variety of routine tasks related to the monitoring of human subjects research, including working closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
• Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day- to- day study and program management. Track progress of projects and create progress reports.  Prepare research reports for research personnel and funding organizations. Ensure the data collection and research protocols follow all sponsor and institution protocols.
• Complete and maintain research training and certification. Assure research team members in area of responsibility comply with all applicable regulatory and other appropriate policies and approved practices. Responsibilities for regulatory activities include:
  • Prepare development and make submission of all regulatory documents including submission of study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. Maintain trial master file and/or regulatory binder.
  • If applicable, provide assistance to study monitors during routine monitor visits or audits
  • Maintain regulatory records throughout the life of the trial to include: submission of all study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. 
• Perform other duties as necessary.

Required Documents:

• Resume/CV
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:

Minimum

51348

Midpoint

65352

Maximum

79356