Position Summary
The Remote Site Manager provides operational leadership and quality oversight across clinical research sites. This role is responsible for training and mentoring Clinical Research Coordinators, maintaining regulatory and protocol compliance, standardizing research processes, and performing final quality reviews of study documentation prior to submission. The position serves as a key resource for ensuring consistency, accuracy, and compliance across all research operations while reporting directly to the Director of Clinical Research.
Key Responsibilities
Train, onboard, and mentor Clinical Research Coordinators and research staff.
Develop and maintain standardized workflows, SOPs, and best practices across sites.
Review source documentation, regulatory files, and study data for completeness, accuracy, and protocol compliance before submission.
Ensure compliance with study protocols, ICH-GCP guidelines, sponsor requirements, and internal SOPs.
Support regulatory document preparation and maintenance of essential study files.
Assist sites with audit readiness, monitoring visit preparation, and corrective action implementation.
Provide ongoing education and retraining to research staff as protocols and processes evolve.
Monitor research quality metrics and identify opportunities for operational improvement.
Serve as a resource for coordinators regarding protocol interpretation, compliance questions, and operational challenges.
Collaborate with investigators, site leadership, sponsors, and operations to maintain high-quality research standards.
Support special research projects and operational initiatives as assigned.
Reporting Structure
Reports directly to the Director of Clinical Research.
Works collaboratively with Principal Investigators, Site Managers, Clinical Research Coordinators, and Regulatory staff.
Qualifications
Experience in clinical research operations.
Strong understanding of ICH-GCP, FDA regulations, and clinical trial processes.
Experience with regulatory documentation and sponsor requirements.
Excellent organizational, leadership, and communication skills.
Ability to train, mentor, and develop research personnel.
Experience with CTMS, EDC, eSource, and electronic regulatory systems preferred.
Work Arrangement
This Remote Site Manager position offers critical operational leadership and quality oversight for clinical research sites, reporting directly to the Director of Clinical Research. You will be instrumental in training and mentoring Clinical Research Coordinators, developing standardized workflows and SOPs, and ensuring rigorous compliance with study protocols, ICH-GCP, and FDA regulations. A core responsibility involves performing final quality reviews of all study documentation and data to guarantee accuracy and completeness before submission, serving as a vital resource for consistency and compliance across all research operations.
The ideal candidate will possess extensive experience in clinical research operations, a strong understanding of regulatory requirements, and excellent organizational, leadership, and communication skills, particularly in developing and mentoring research personnel. This full-time remote role requires occasional travel to research sites for training and operational support, and experience with clinical trial management and electronic systems (CTMS, EDC, eSource) is preferred.
