Project Specialist-CTC

Loma Linda University Health; Loma Linda (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Loma Linda University Health is seeking a Project Specialist to support the end-to-end operational readiness and execution of clinical research. The role serves as a subject matter expert for Oncore and maintains study records in LLEAP/EPIC, collaborating with coordinators, investigators, and cross-functional teams to ensure studies are accurately built, activated, and maintained.

Responsibilities include supporting submissions to the Clinical Trial Center (CTC), advancing billing quality

Qualifications

• Bachelor's Degree in health-related field preferred.
• 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.
• Requires working knowledge of HIPAA guidelines.

Responsibilities

• Support end-to-end operational readiness and execution of clinical research.
• Serve as SME for Oncore and create/maintain study records in LLEAP/EPIC.
• Collaborate with coordinators, investigators, and cross-functional teams to ensure studies are activated and maintained.
• Assist submissions to the Clinical Trial Center (CTC).
• Advance research billing quality improvement initiatives and oversee subject stipend processes.
• Support Study Startup and Study Finance teams and maintain the Center's digital presence.

Skills

Organizational skills

Prioritization

English communication

Education

Bachelor's degree in health-related field

2 years clinical research experience

Tools

CTMS

EMR systems

Job description

Job Summary: 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.

Education and Experience: Bachelor's Degree in health-related field preferred. Minimum two years in clinical research administration, operations, CTMS/EMR build or study finance required.

Knowledge and Skills: Working knowledge of clinical research regulations (ICH-GCP, FDA, OHRP) and institutional workflows. Proficiency with CTMS and electronic medical record systems CMS Billing requirements and strong understanding of clinical research protocols. Requires 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.

Licensures and Certifications: ACRP or Certified Clinical Research Professional (CCRP) through SOCRA preferred.

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