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.
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