Site Management Assistant
hace 1 mes
Provide centralized task support on all assigned projects. Ensure all work is conducted in accordance with SOPs, work instructions, policies, good clinical practices and applicable regulatory requirements. Comply with all associated quality and timeliness metrics.
Essential Functions
- Liaise with project teams and third party vendors to prepare and ship Investigator Site File (ISF) binders to contracted clinical sites.
- Assist Clinical Research Associates (CRAs) and Site Managers 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 ongoing reviews of study files to ensure completeness, quality, and timeliness.
- Assist project teams with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Qualifications:
- Bachelor's degree in Life Sciences preferred
- 12 years of administrative experience is a plus
- Equivalent combination of education, training and experience.
- Computer skills including strong working knowledge of Microsoft Word, Excel and PowerPoint.
- Strong 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.
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