Project Specialist-CTC

Loma Linda University Health•Loma Linda, CA

26d•Onsite

About The Position

The Project Specialist supports the end-to-end operational readiness and execution of clinical research at Loma Linda by serving as a subject matter expert (SME) for Oncore and by creating and maintaining study records in LLEAP/EPIC. Partners closely with coordinators, investigators, and cross-functional teams to ensure studies are accurately built, activated, and maintained. Supports submissions to the Clinical Trial Center (CTC), advances research billing quality improvement initiatives, oversees subject stipend processes, assists the Study Startup and Study Finance teams and maintains the Center’s digital presence across institutional websites and pages. Performs other duties as needed.

Requirements

Minimum two years in clinical research administration, operations, CTMS/EMR build or study finance required.
Working knowledge of clinical research regulations (ICH-GCP, FDA, OHRP) and institutional workflows.
Proficiency with CTMS and electronic medical record systems.
Knowledge of CMS Billing requirements.
Strong understanding of clinical research protocols.
Working knowledge of HIPAA guidelines.
Strong organizational and prioritizing skills.
Able to read; write legibly; speak in English with professional quality.
Use computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint).
Operate/troubleshoot basic office equipment required for the position.
Relate and communicate positively, effectively, and professionally with others.
Work calmly and respond courteously when under pressure.
Collaborate and accept direction.
Communicate effectively in English in person, in writing, and on the telephone.
Think critically.
Manage multiple assignments effectively.
Organize and prioritize workload.
Work well under pressure.
Problem solve.
Recall information with accuracy.
Pay close attention to detail.
Work independently with minimal supervision.
Distinguish colors as necessary.
Hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace.
See adequately to read computer screens, and written documents necessary to the position.

Nice To Haves

Bachelor's Degree in health-related field preferred.
ACRP or Certified Clinical Research Professional (CCRP) through SOCRA preferred.

Responsibilities

Support the end-to-end operational readiness and execution of clinical research.
Serve as a subject matter expert (SME) for Oncore.
Create and maintain study records in LLEAP/EPIC.
Partner with coordinators, investigators, and cross-functional teams to ensure studies are accurately built, activated, and maintained.
Support submissions to the Clinical Trial Center (CTC).
Advance research billing quality improvement initiatives.
Oversee subject stipend processes.
Assist the Study Startup and Study Finance teams.
Maintain the Center’s digital presence across institutional websites and pages.
Perform other duties as needed.