Job Title: Clinical Operations Project Specialist

Work Location: Remote

Summary:

Seeking a detail-oriented and adaptable Clinical Operations Project Specialist to support the operational execution of clinical trials. This role involves coordinating study activities, maintaining essential documentation, supporting eCOA system implementation, and ensuring high-quality data collection. The ideal candidate excels in communication, thrives in collaborative environments, and is motivated to contribute to digital innovation in clinical research.

Responsibilities:

• Coordinate and maintain essential study documents, ensuring accuracy and compliance with regulatory standards.
• Facilitate scheduling and monitoring of central rater appointments, supporting timely and accurate data collection.
• Serve as a liaison to troubleshoot technical and operational issues related to eCOA platforms and study workflows.
• Track key study metrics, monitor participant compliance, and escalate risks or discrepancies as needed.
• Assist with eCOA system implementation, including user training, system testing, and deployment coordination.
• Prepare meeting materials, document action items, and follow up to ensure timely resolution of outstanding issues.
• Collaborate with project management to monitor timelines, deliverables, and ensure alignment with project goals.
• Provide status updates to stakeholders, maintain proper archival of study documents, and support site monitoring activities.

Qualifications:

• Bachelor’s Degree (or equivalent) in life sciences or a related field, or equivalent combination of education and experience.
• Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable US regulatory requirements.
• Relevant clinical research experience, including exposure to eCOA platforms and electronic data collection.
• Proficiency with data collection platforms, especially eCOA systems, and Microsoft Office suite.
• Excellent written and verbal communication skills for both technical and non-technical audiences.
• Strong organizational, prioritization, and multitasking abilities with attention to detail.
• Demonstrated ability to collaborate across functional teams and external partners.
• Proactive problem-solving skills and ability to manage multiple tasks within tight deadlines.

Published Category: Clinical Operations & Development