Remote Clinical Trials Operations Specialist

ProPharma; Raleigh (NC); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProPharma is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies. You will work closely with study teams to ensure compliant, timely study execution.

The role emphasizes strong communication, organization, and documentation skills, with exposure to study systems such as CTMS, eTMF, and EDC. A bachelor’s degree is preferred, and hybrid work is available.

Qualifications

• 2+ years of experience in the pharmaceutical, biotechnology, CRO, or clinical research environment is preferred.
• At least 1 year of experience in a Clinical Project Specialist, Clinical Trial Assistant, Clinical Trial Coordinator, Project Coordinator, or comparable clinical operations support role is strongly preferred.
• Bachelor’s degree is preferred; comparable depth and breadth of relevant training may be considered.

Responsibilities

• Performs administrative and project support activities related to clinical trial execution, including assisting with study documents and information.
• Supports day-to-day operations of clinical studies in compliance with SOPs, ICH/GCP, and regulatory requirements.
• Assists with document collection, tracking, and reconciliation.
• Develops and distributes site binders and study materials.
• Tracks study information using databases, trackers, and other tools.
• Sets up meetings, prepares agendas, takes minutes, and distributes materials.
• Identifies and escalates issues or risks impacting deliverables.
• Collaborates with study teams and stakeholders to complete activities and deliverables.
• Supports study systems and documentation, including CTMS, eTMF, EDC, IVRS/IWRS.

Skills

Verbal & written communication

Organization & multitasking

MS Office proficiency

CTMS / EDC experience

Independent work

Education

Bachelor's degree preferred

Tools

CTMS

eTMF

EDC

IVRS/IWRS

Job description

ProPharma is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies. You will work closely with study teams to ensure compliant, timely study execution.

The role emphasizes strong communication, organization, and documentation skills, with exposure to study systems such as CTMS, eTMF, and EDC. A bachelor’s degree is preferred, and hybrid work is available.