Associate Researcher

Sotalent; North Carolina; On-site; USD 65,000 - 85,000; Full time

Job summary

Sotalent is seeking a Research Associate to support monitoring and management of clinical sites, ensuring studies follow protocols, GCP, and regulatory standards while data quality remains high.

You will conduct site monitoring visits, support site recruitment planning, deliver training, track milestones, maintain TMF/ISF documentation, and collaborate with cross-functional teams to enable successful project delivery.

Qualifications

• Bachelor’s or equivalent in science, health, or related field.
• Solid knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Conduct site monitoring activities per study protocol and regulatory requirements.
• Support site recruitment planning and monitor progress against timelines.
• Deliver protocol and study-related training to sites and communicate updates.
• Evaluate site compliance with protocols, GCP, and regulations, escalating issues.
• Track milestones: submissions, approvals, enrollment, CRF completion, data queries.
• Ensure TMF and ISF documentation is complete and well-maintained.
• Prepare monitoring reports, correspondence, and required study docs.
• Collaborate with cross-functional teams to deliver projects.
• Assist with site-level recruitment planning and tracking as needed.
• Support site financial administration and invoicing per study agreements.

Skills

Communication

Time management

Attention to detail

Analytical skills

Problem solving

Organisational skills

Team collaboration

Education

Bachelor's degree in life sciences or healthcare

Tools

Microsoft Office

Job description

An opportunity is available for a Research Associate to support the monitoring and management of clinical research sites. The role is responsible for ensuring clinical studies are conducted in accordance with study protocols, regulatory requirements, and applicable industry guidelines while maintaining high standards of data quality and site compliance.

Key Responsibilities

• Conduct site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols and regulatory requirements.
• Support study sites with participant recruitment planning and monitor recruitment progress against project timelines.
• Deliver protocol and study-related training to assigned sites and maintain regular communication to address study progress and operational issues.
• Evaluate site compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements, escalating quality concerns where appropriate.
• Track study milestones, including regulatory submissions, approvals, participant enrolment, case report form (CRF) completion, and data query resolution.
• Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
• Prepare monitoring reports, follow-up correspondence, and other required study documentation.
• Collaborate with cross-functional study teams to support successful project delivery.
• Assist with site-level recruitment planning and tracking where required.
• Support site financial administration and invoice processing in accordance with study agreements, where applicable.

Requirements

• Bachelor's degree in a scientific, life sciences, or healthcare-related discipline preferred, or an equivalent combination of education and experience.
• Previous clinical research monitoring experience or completion of a Clinical Research Associate (CRA) training programme may be required.
• Working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulations.
• Understanding of clinical study protocols and therapeutic areas.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Excellent organisational, analytical, and problem-solving abilities.
• Effective time management and attention to detail.
• Ability to build and maintain productive working relationships with internal teams, clinical sites, and external stakeholders.