Clinical Information Specialist I

Department:
RI Office of Clinical Trials Administration (OCTA)

-----

Research Systems Operations
Position Title:
Clinical Information Specialist I
Job Family Group:
Professional Staff
Job Description Summary:
This individual will provide end user support for systems managed and supported by the University of Kansas Research Institute including, but not limited to, Complion. This position will be responsible for creating and maintaining records and supporting data quality in Complion eRegulatory binders as well as the Velos Clinical Trials Management System. The individual will also be responsible for systems training and support.
Job Description:

Required Qualifications:

• Analytical and problem-solving skills
• Organization skills

Required Qualifications:

• Bachelor’s degree in computer science, mathematics, other technology-related discipline, OR 4 years equivalent relevant experience.
• Previous work experience with databases, specifically building forms and queries.
• The candidate should possess effective communication and verbal skills as evidence by resume and interview.
• Must have experience in project management as evidence by application materials

Preferred Qualifications:

• 2 years of experience in an academic or health-related research environment.
• Knowledge of ICH/GCP guidelines in regard to clinical trials.

Job Duties Outlined:

User Management and Support—

• Manage software/application user roles and permissions. Create accounts and expire or remove termed accounts. Provide training for various levels of end users based on vendor provided training (onsite, webinars, conference calls, etc.) and training documents.
• Promote software/application availability to intended users.
• Works with Velos team to develop needed reports for end users.
• Train current and future RI staff in Complion and other systems supported software.  
• Provides advanced reporting to customers through the use of Complion developed reports.
• Monitor software/application logs
• Keep up with new features and modify the software/application configuration as needed.
• Work with the vendor to schedule updates
• Work with the vendor to coordinate downtime, when the software/application is unavailable to end-users, as necessary.
• Update third-party applications (e.g. Java, Flash) utilized/required by the software/application when feasible.
• Troubleshoot, replicate, and resolve software/application issues when they arise, and at any time.
• Contact the vendor on all issues that require vendor intervention.

• Provide reference information to Technical Support staff in Information Resources.

• Archive data when necessary, understand the software/application data recovery process and manage data security
• Assist with data quality management effort

• Create, modify and maintain eRegulatory binders for study team members. C
• Create and modify overall menus/drop-down choices, etc. to support functionality.
• Create, modify and maintain standardized templates for trials.
• Create, modify and maintain clinical databases to support protocols.
• Update and maintain system to remain compliant with federal and other regulatory guidelines.

• Participates in internal quality assurance efforts and system performance monitoring.
• Responsible for creating and maintaining eRegulatory management systems for individual clinical studies and other research projects; assist in training research staff in data entry and routine data management, conduct regular data quality checks, generate routine data reports for projects approved by the Director as needed.
• Develop and maintain documentation for all technical processes related to database development projects, Standard Operating Procedures (SOPs) and development of system user manuals related to the clinical information management system.
• Performs other duties as may be assigned by supervisor.

Required Documents:

Resume/CV

Cover Letter

Employee Type:

Regular

Time Type:

Full time

Pay Range:
51,348.00 - 65,352.00 - 79,356.00 USD Annual

About Us

The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care.

Equal Employment Opportunity Statement

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.

Nondiscrimination, Equal Opportunity, and Affirmative Action Policy

http://policy.ku.edu/IOA/nondiscrimination

Title IX Policy

https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/

Kansas Family Leave Act

https://www.da.ks.gov/ps/subject/fmlahmpg.html

Clery Disclosure Act

https://www.kumc.edu/public-safety/clery-information/annual-security-report.html

EEO Statement

http://www.kumc.edu/Documents/ioa/EO Statement2019.pdf

Pay Transparency Notice

https://https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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

Minimum

51348

Midpoint

65352

Maximum

79356

Department:
RI Office of Clinical Trials Administration (OCTA)

-----

Research Systems Operations
Position Title:
Clinical Information Specialist I
Job Family Group:
Professional Staff
Job Description Summary:
This individual will provide end user support for systems managed and supported by the University of Kansas Research Institute including, but not limited to, Complion. This position will be responsible for creating and maintaining records and supporting data quality in Complion eRegulatory binders as well as the Velos Clinical Trials Management System. The individual will also be responsible for systems training and support.
Job Description:

Required Qualifications:

• Analytical and problem-solving skills
• Organization skills

Required Qualifications:

• Bachelor’s degree in computer science, mathematics, other technology-related discipline, OR 4 years equivalent relevant experience.
• Previous work experience with databases, specifically building forms and queries.
• The candidate should possess effective communication and verbal skills as evidence by resume and interview.
• Must have experience in project management as evidence by application materials

Preferred Qualifications:

• 2 years of experience in an academic or health-related research environment.
• Knowledge of ICH/GCP guidelines in regard to clinical trials.

Job Duties Outlined:

User Management and Support—

• Manage software/application user roles and permissions. Create accounts and expire or remove termed accounts. Provide training for various levels of end users based on vendor provided training (onsite, webinars, conference calls, etc.) and training documents.
• Promote software/application availability to intended users.
• Works with Velos team to develop needed reports for end users.
• Train current and future RI staff in Complion and other systems supported software.  
• Provides advanced reporting to customers through the use of Complion developed reports.
• Monitor software/application logs
• Keep up with new features and modify the software/application configuration as needed.
• Work with the vendor to schedule updates
• Work with the vendor to coordinate downtime, when the software/application is unavailable to end-users, as necessary.
• Update third-party applications (e.g. Java, Flash) utilized/required by the software/application when feasible.
• Troubleshoot, replicate, and resolve software/application issues when they arise, and at any time.
• Contact the vendor on all issues that require vendor intervention.

• Provide reference information to Technical Support staff in Information Resources.

• Archive data when necessary, understand the software/application data recovery process and manage data security
• Assist with data quality management effort

• Create, modify and maintain eRegulatory binders for study team members. C
• Create and modify overall menus/drop-down choices, etc. to support functionality.
• Create, modify and maintain standardized templates for trials.
• Create, modify and maintain clinical databases to support protocols.
• Update and maintain system to remain compliant with federal and other regulatory guidelines.

• Participates in internal quality assurance efforts and system performance monitoring.
• Responsible for creating and maintaining eRegulatory management systems for individual clinical studies and other research projects; assist in training research staff in data entry and routine data management, conduct regular data quality checks, generate routine data reports for projects approved by the Director as needed.
• Develop and maintain documentation for all technical processes related to database development projects, Standard Operating Procedures (SOPs) and development of system user manuals related to the clinical information management system.
• Performs other duties as may be assigned by supervisor.

Required Documents:

Resume/CV

Cover Letter

Employee Type:

Regular

Time Type:

Full time

Pay Range:
51,348.00 - 65,352.00 - 79,356.00 USD Annual

About Us

The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care.

Equal Employment Opportunity Statement

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.

Nondiscrimination, Equal Opportunity, and Affirmative Action Policy

http://policy.ku.edu/IOA/nondiscrimination

Title IX Policy

https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/

Kansas Family Leave Act

https://www.da.ks.gov/ps/subject/fmlahmpg.html

Clery Disclosure Act

https://www.kumc.edu/public-safety/clery-information/annual-security-report.html

EEO Statement

http://www.kumc.edu/Documents/ioa/EO Statement2019.pdf

Pay Transparency Notice

https://https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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

Minimum

51348

Midpoint

65352

Maximum

79356