Clinical Trial Assistant

Jobtailor; California (MO); On-site; USD 48,000 - 62,000; Full time

Job summary

Jobtailor is seeking an administrative support specialist to assist the clinical team with document management, regulatory compliance, and data tracking within TMF and related systems. The role involves handling study documentation, archiving, and coordinating communications across the clinical team.

Applicants should have a Bachelor's degree and at least 3 years of administrative experience, plus strong MS Word/Excel/PowerPoint skills and English communication abilities.

Qualifications

• Bachelor's degree required.
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.

Responsibilities

• Assist CRAs and RSU with updating and maintaining clinical documents (TMF) within project timelines.
• Assist with preparation, handling, distribution, filing and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with tracking of Clinical Trial Supplies and maintenance of tracking information.
• Assist with tracking and management of CRFs, queries and clinical data flow.
• Act as central contact for designated project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Written and verbal communication

Time management

Organizational skills

Interpersonal relations

Education

Bachelor's degree

Job description

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Requirements

• Bachelor's Degree Required
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Core Competencies

Demonstrates expertise in clinical documentation management, including Trial Master File (TMF) maintenance and compliance tracking, while effectively communicating and collaborating with clinical teams. Proficient in adhering to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.