Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
May support scheduling of client and/or internal meetings.
May review and track local regulatory documents.
Maintains vendor trackers.
Supports start-up team in Regulatory submissions.
Works directly with sites to obtain documents related to site selection.
Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
Qualifications
Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Knowledge, Skills, Abilities
Ability to work in a team or independently as required.
Flexibility to reprioritize workload to meet changing project timelines.
Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
Good English language and grammar skills.
Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
Effective oral and written communication skills.
Crucial judgment and decision-making skills.
Capable of accurately following project work instructions.
Ablity to work independently and complete tasks on time and to a high standard.
