Address
Form of workPosting Details
Posting Details
Job Title
Research Administrative Coordinator Pr
Requisition Number
RE43054
Working Title
Clinical Research Associate Senior II
Department Name
40133:Clinical Research Support Office
Work Location
Lexington, KY
Grade Level
45
Salary Range
$46,806-77,226/year
Type of Position
Staff
Position Time Status
Full-Time
Required Education
MA
Click here for more information about equivalencies:
https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience
5 yrs
Required License/Registration/Certification
None
Physical Requirements
Ability to sit for long periods of time utilizing mouse, keyboard, computer and telephone. Ability to lift, push, or pull objects up to 50 lbs.
Shift
Monday - Friday, Day Shift; 8:00am - 5:00pm
Some early or late meetings required.
Job Summary
This is a hybrid/remote eligible position!
The University of Kentucky Clinical Research Support Office (CRSO) provides support to investigators and study teams conducting clinical research. Recently the CRSO expanded its scope of services from clinical trials to clinical research management. This expansion includes the proper review of each clinical research study to determine: the level of management in the CTMS system, the data entry needed, the Epic participation determination, the calendar services including the financial calendars, and the ongoing technical assistance once the study is in Epic. Services provided by the CRSO include maintaining a clinical trial management system (CTMS), conducting coverage analysis, and billing review for all clinical research studies, financial management of clinical research studies in collaboration with CCTS and other partners and providing regulatory services.
The CRSO is seeking qualified candidates for a Clinical Research Associate Senior position. This position performs detailed reviews of complex study protocols, budgets, informed consent forms, contracts, FDA documents, and other relevant study documents to determine the minimum data requirements based on the CRSO approved scope of work. Determine the Epic participation based on the billing and other needs for the management of the research study and develop the financial and clinical comprehensive calendars. Provide training to CRSO staff on various processes including data entry in the CTMS system, the minimum footprint data requirements, internal processes for both regular and financial calendars and the Epic management of subjects.
The role performs its work collaboratively with investigators, study teams, clinical research coordinators, and other research staff while serving as a resource on the CTMS content as it relates to clinical Research Administrative support and as an integral component to maintaining proper billing integrity and compliant standards. This role will also cross-train on clinical trial budget data entry and charge review process during first tier while monitoring the initial dashboard from Epic. The ideal candidate works well independently and with teams, is organized, exercises sound judgement, and possesses attention to detail.
It is preferred that candidates have a minimum of five years' work experience in clinical research, especially with calendars and the CTMS system OnCore - along with a Bachelor's or Master's degree in a health-related discipline or equivalent professional experience.
IMPORTANT: Resumes cannot be substituted for a completed application. All relevant work history must be listed on your application for each unique position/job-role held.
Incomplete applications could disqualify you from being considered for this position.
Skills / Knowledge / Abilities
Regulatory knowledge, medical terminology and clinical research knowledge, strong competency in Microsoft Office products (especially Word, Excel, PowerPoint).
Does this position have supervisory responsibilities?
No
Preferred Education/Experience
It is preferred that the candidate have work experience in clinical research with some graduate courses if possible or a related certification in Research.
It is also preferred to have experience with OnCore calendar building and data management, especially experience with Epic.
Deadline to Apply
01/08/2024
University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors the University of Kentucky is a Tobacco & Drug Free campus.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.
Posting Details
Job Title
Research Administrative Coordinator Pr
Requisition Number
RE43054
Working Title
Clinical Research Associate Senior II
Department Name
40133:Clinical Research Support Office
Work Location
Lexington, KY
Grade Level
45
Salary Range
$46,806-77,226/year
Type of Position
Staff
Position Time Status
Full-Time
Required Education
MA
Click here for more information about equivalencies:
https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience
5 yrs
Required License/Registration/Certification
None
Physical Requirements
Ability to sit for long periods of time utilizing mouse, keyboard, computer and telephone. Ability to lift, push, or pull objects up to 50 lbs.
Shift
Monday - Friday, Day Shift; 8:00am - 5:00pm
Some early or late meetings required.
Job Summary
This is a hybrid/remote eligible position!
The University of Kentucky Clinical Research Support Office (CRSO) provides support to investigators and study teams conducting clinical research. Recently the CRSO expanded its scope of services from clinical trials to clinical research management. This expansion includes the proper review of each clinical research study to determine: the level of management in the CTMS system, the data entry needed, the Epic participation determination, the calendar services including the financial calendars, and the ongoing technical assistance once the study is in Epic. Services provided by the CRSO include maintaining a clinical trial management system (CTMS), conducting coverage analysis, and billing review for all clinical research studies, financial management of clinical research studies in collaboration with CCTS and other partners and providing regulatory services.
The CRSO is seeking qualified candidates for a Clinical Research Associate Senior position. This position performs detailed reviews of complex study protocols, budgets, informed consent forms, contracts, FDA documents, and other relevant study documents to determine the minimum data requirements based on the CRSO approved scope of work. Determine the Epic participation based on the billing and other needs for the management of the research study and develop the financial and clinical comprehensive calendars. Provide training to CRSO staff on various processes including data entry in the CTMS system, the minimum footprint data requirements, internal processes for both regular and financial calendars and the Epic management of subjects.
The role performs its work collaboratively with investigators, study teams, clinical research coordinators, and other research staff while serving as a resource on the CTMS content as it relates to clinical Research Administrative support and as an integral component to maintaining proper billing integrity and compliant standards. This role will also cross-train on clinical trial budget data entry and charge review process during first tier while monitoring the initial dashboard from Epic. The ideal candidate works well independently and with teams, is organized, exercises sound judgement, and possesses attention to detail.
It is preferred that candidates have a minimum of five years' work experience in clinical research, especially with calendars and the CTMS system OnCore - along with a Bachelor's or Master's degree in a health-related discipline or equivalent professional experience.
IMPORTANT: Resumes cannot be substituted for a completed application. All relevant work history must be listed on your application for each unique position/job-role held.
Incomplete applications could disqualify you from being considered for this position.
Skills / Knowledge / Abilities
Regulatory knowledge, medical terminology and clinical research knowledge, strong competency in Microsoft Office products (especially Word, Excel, PowerPoint).
Does this position have supervisory responsibilities?
No
Preferred Education/Experience
It is preferred that the candidate have work experience in clinical research with some graduate courses if possible or a related certification in Research.
It is also preferred to have experience with OnCore calendar building and data management, especially experience with Epic.
Deadline to Apply
01/08/2024
University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors the University of Kentucky is a Tobacco & Drug Free campus.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.
