Purpose:
Under the direction of the Senior OnCore Administrator, this position is responsible for coordinating the intake and initial setup of clinical research studies within the OnCore Clinical Trials Management System (CTMS). It plays a critical role in supporting clinical research operations by managing the protocol build process. This position serves as a liaison between study teams and external vendors, ensuring timely and accurate setup of protocol shells, study calendars, and budgets. The specialist is responsible for initiating builds, maintaining task lists, implementing quality control processes to ensure data integrity and compliance, and training staff.
Please note that this position is in-office three days per week.
Responsibilities:
Create and configure protocol shells in OnCore for new and existing studies
Input study information received from study teams into OnCore
Manage the study calendar and budget build process within OnCore
Implement quality control (QC) checks to ensure accuracy of calendar and budget details
Build small study specifications directly in OnCore when applicable
Act as the primary liaison between study teams and external vendors
Submit protocol build requests to vendors and respond to vendor queries in a timely manner
Follow up with study teams as needed to gather missing information or clarify requirements
Process New Study Start-Up Forms and Protocol Amendments
Maintain and update task lists to reflect current project status
Track all protocol builds and maintain documentation for audit readiness
Train staff as necessary
Perform additional duties as assigned in support of calendar build coordination
Bachelor's degree in a health-related, scientific, or technical field preferred
Experience with OnCore or other CTMS platforms strongly preferred
Strong organizational and communication skills
Ability to manage multiple projects and deadlines
Detail-oriented with a focus on data accuracy and quality assurance
Comfortable working independently and collaboratively across teamsLicensure, Certifications, and Clearances:UPMC is an Equal Opportunity Employer/Disability/Veteran
Under the direction of the Senior OnCore Administrator, this position is responsible for coordinating the intake and initial setup of clinical research studies within the OnCore Clinical Trials Management System (CTMS). It plays a critical role in supporting clinical research operations by managing the protocol build process. This position serves as a liaison between study teams and external vendors, ensuring timely and accurate setup of protocol shells, study calendars, and budgets. The specialist is responsible for initiating builds, maintaining task lists, implementing quality control processes to ensure data integrity and compliance, and training staff.
Please note that this position is in-office three days per week.
Responsibilities:
Create and configure protocol shells in OnCore for new and existing studies
Input study information received from study teams into OnCore
Manage the study calendar and budget build process within OnCore
Implement quality control (QC) checks to ensure accuracy of calendar and budget details
Build small study specifications directly in OnCore when applicable
Act as the primary liaison between study teams and external vendors
Submit protocol build requests to vendors and respond to vendor queries in a timely manner
Follow up with study teams as needed to gather missing information or clarify requirements
Process New Study Start-Up Forms and Protocol Amendments
Maintain and update task lists to reflect current project status
Track all protocol builds and maintain documentation for audit readiness
Train staff as necessary
Perform additional duties as assigned in support of calendar build coordination
Bachelor's degree in a health-related, scientific, or technical field preferred
Experience with OnCore or other CTMS platforms strongly preferred
Strong organizational and communication skills
Ability to manage multiple projects and deadlines
Detail-oriented with a focus on data accuracy and quality assurance
Comfortable working independently and collaboratively across teamsLicensure, Certifications, and Clearances:UPMC is an Equal Opportunity Employer/Disability/Veteran