Note: The job is a remote job and is open to candidates in USA. Russell Tobin is recruiting for an unnamed biotechnology organization seeking a Clinical Trial Assistant to support clinical operations and outsourced clinical trials. The role coordinates study documentation, vendors, trial tracking, and regulatory compliance from planning through closeout.

Responsibilities

• Support Clinical Trial Managers with the day-to-day coordination and execution of clinical studies
• Prepare and distribute meeting agendas, minutes, monthly status reports, and project updates for internal and external stakeholders
• Assist with study start-up activities, including preparing and reviewing study documents, monitoring plans, laboratory manuals, patient diaries, pharmacy manuals, site procedures, and case report form guidelines
• Support the tracking of participant recruitment, monitoring visits, protocol deviations, compliance issues, and other study-related activities across clinical sites
• Coordinate with Contract Research Organizations (CROs), vendors, and investigator sites to communicate study updates and resolve operational issues
• Collect, review, organize, and file essential site documents and support Trial Master File (TMF) maintenance
• Track clinical supplies and support study systems such as Interactive Web Response Systems (IWRS), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS)
• Follow International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, applicable regulatory requirements, study protocols, and standard operating procedures
• Assist with study risk assessments, corrective action plans, quality assurance activities, audits, and inspections
• Participate in clinical study team meetings, CRO and vendor discussions, investigator site meetings, and investigator meetings as needed
• Escalate out-of-scope issues and communicate study risks or concerns to the Clinical Trial Manager promptly
• Support cross-functional collaboration to ensure clinical studies remain organized, compliant, and on schedule

Skills

• Bachelor's degree in Biomedical Sciences or a related scientific discipline
• Minimum 2 years of clinical research experience
• Demonstrated experience working in a clinical research environment and familiarity with clinical study protocols
• Working knowledge of ICH-GCP guidelines and clinical research regulations
• Familiarity with clinical trial documentation, essential documents, and Trial Master File maintenance
• Excellent written and verbal communication skills
• Strong organizational, multitasking, prioritization, and time-management abilities
• Ability to collaborate with clinical teams, CROs, vendors, and investigator sites while managing multiple study activities

Benefits

• For workers in the United States, eligible employees are offered comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Company Overview