In this role, you will be working under general supervision, engaging in routine tasks and receiving detailed instructions for new assignments. Your primary responsibilities will include tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools. Additionally, you may assist with the development of documents for site binders and participate in the quality assurance of data and documents under close supervision.
You will also arrange meeting logistics, draft meeting agendas, and assist in preparing meeting minutes. This role requires interaction with other departments, as directed, to complete assigned tasks, and assisting in filing documents in either paper or electronic Trial Master Files (TMF).
To succeed in this position, excellent verbal and written communication skills, as well as strong interpersonal skills, are essential.
Skills
Familiarity with Word, PowerPoint, and Excel
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs is a plus
Ability to work both independently and as part of a team
Responsibilities
Tracking and preparing study-specific information using databases and spreadsheets
Assisting with the development of site binders
Reviewing and participating in the quality assurance of data or documents
Arranging meeting logistics and preparing meeting agendas and minutes
Filing documents in Trial Master Files (TMF)
Employment Type: Contractor
Seniority level
Entry level
Employment type
Contract
Job function
Project Management and Information Technology
Industries
Information Technology & Services
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