Job Description

Job Location Monroe, LA 71201

Sygnola is a Clinical Research Organization (CRO) dedicated to advancing wound medicine research through innovative clinical trials, rigorous methodologies, and expert services. With over 100 years of combined specialized experience in wound care, we focus on separating the signal from the noise in clinical research to deliver reliable outcomes and improve patient care. Our expertise encompasses clinical trial management, patient recruitment, data analysis, regulatory compliance, manuscript preparation, publication support, and regulatory submissions.

Sygnola Clinical Research Organization is seeking motivated Regional Research Specialists (RRS) to manage the activation, maintenance, and performance of 9-15 MedCentris investigator sites within designated geographic regions. Reporting directly to the Research Site Manager (RSM), the RRS will ensure seamless site operations, protocol adherence, and enrollment success across multiple clinical trials. This primarily remote role offers flexibility while requiring hands-on site engagement through travel, strong organizational skills, and a focus on achieving regional enrollment targets in a fast-paced clinical research environment.

Key Responsibilities

• Site Activation and Maintenance: Oversee the activation process for assigned MedCentris investigator sites, including feasibility assessments, regulatory submissions, contract support, and startup activities. Manage ongoing trial maintenance to ensure protocol compliance, high-quality data collection, and timely resolution of site issues.
• Enrollment and Performance Optimization: Develop and implement strategies to drive subject enrollment within the region, monitoring progress toward quarterly targets (e.g., 15 subjects per trial per quarter for bonus eligibility). Track and report on enrollment metrics, identifying and addressing barriers to recruitment.
• Site Visits and Relationship Management: Conduct regular on-site visits for training, monitoring, audits, and support of investigators and site staff. Build and maintain strong relationships to foster collaboration and site performance.
• Compliance and Quality Assurance: Ensure all assigned sites adhere to Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and Sygnola's standard operating procedures. Perform risk-based monitoring, manage essential documents, and escalate issues as appropriate.
• Reporting and Collaboration: Provide regular updates and reports on regional site metrics, enrollment status, and operational challenges to the Research Site Manager. Collaborate with cross-functional teams, including project managers and regulatory affairs, to support overall trial objectives.
• Process Improvement: Contribute to regional efficiencies by identifying best practices, supporting site staff training, and recommending improvements to site management processes.

Qualifications and Requirements

• Education: Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree or relevant certifications preferred.
• 
  
  Experience: Minimum of 3-5 years in clinical research operations, with experience in site coordination, monitoring, or management. Prior work with investigator sites in a Clinical Research Organization (CRO) or similar setting is highly desirable.
• Skills:
  • Solid understanding of clinical trial processes, including site activation, monitoring, and enrollment techniques.
  • Excellent organizational, communication, and interpersonal skills for managing multiple sites and stakeholders.
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) tools, and Microsoft Office Suite.
  • Ability to analyze regional performance data and implement targeted improvements.
• Other Requirements: Willingness to travel regularly to sites within the assigned region. Must have a valid driver's license and ability to pass background checks. Comfortable working primarily remotely with occasional headquarters attendance as requested.
• Preferred: Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA); experience managing multiple sites simultaneously.

Sygnola is an equal opportunity employer committed to diversity and inclusion. We encourage applications from qualified candidates of all backgrounds. To apply, please submit your resume and cover letter to dr.aferguson@sygnola.com.

Qualifications