This is a remote position.
Position OverviewWe are seeking a motivated and detail-oriented Clinical Research Assistant to join our growing clinical operations team. In this role, you will support the coordination and administration of clinical research studies while ensuring study documentation, data quality, and regulatory compliance are maintained throughout the research process.
This position is ideal for someone with excellent organizational skills, strong attention to detail, and an interest in contributing to clinical research in a remote environment.
- Assist with the day-to-day management of assigned clinical studies.
- Maintain investigator site files, regulatory binders, and essential study documents.
- Prepare, review, and file research documentation in accordance with study requirements.
- Support participant scheduling and study visit coordination.
- Enter, verify, and reconcile clinical data within electronic research systems.
- Monitor study timelines and assist with tracking project deliverables.
- Communicate effectively with investigators, sponsors, study participants, and internal research teams.
- Identify and escalate documentation discrepancies or protocol deviations when appropriate.
- Ensure research activities are conducted in compliance with ICH Good Clinical Practice (GCP), study protocols, and applicable regulatory requirements.
- Perform additional administrative and research support duties as assigned.
Requirements Qualifications
Required
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related discipline, or equivalent healthcare experience.
- Strong organizational and problem-solving abilities.
- Excellent verbal and written communication skills.
- High level of accuracy and attention to detail.
- Proficiency with Microsoft Office and web-based software applications.
- Ability to manage multiple priorities while working independently in a remote setting.
- Previous experience supporting clinical research or healthcare operations.
- Familiarity with ICH-GCP guidelines and FDA regulations.
- Experience using Electronic Data Capture (EDC), CTMS, or eTMF systems.
- Knowledge of clinical trial documentation and research workflows.
- Full-time
- Monday through Friday
- Standard business hours
Benefits Benefits
- Competitive salary
- Comprehensive medical, dental, and vision coverage
- 401(k) with employer contribution
- Paid time off and company holidays
- Remote work environment
- Professional development and career advancement opportunities
Skills Required
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or related discipline (or equivalent healthcare experience)
- Strong organizational and problem-solving abilities
- Excellent verbal and written communication skills
- High level of accuracy and attention to detail
- Proficiency with Microsoft Office and web-based software applications
- Ability to manage multiple priorities while working independently in a remote setting
- Previous experience supporting clinical research or healthcare operations
- Familiarity with ICH-GCP guidelines and FDA regulations
- Experience using Electronic Data Capture (EDC), CTMS, or eTMF systems
- Knowledge of clinical trial documentation and research workflows
What We Do
Allen Spolden specializes in clinical research operations management and provides tailored workforce solutions for clinical research organizations, pharmaceutical, biotech, and healthcare sectors. They offer services in clinical research, data management, regulatory affairs, and talent acquisition.
