Clinical Project Assistant (12mths FTC)

仕事内容

POSITION OVERVIEW:

With guidance, performs or supports other Clinical Operations team members in the start-up, maintenance and close-out of clinical studies (clinical trials and PMS studies). Tracks and prepares study-specific information, reviews and participates in the quality assurance of data and/or documents, arranges and assists with meetings and meeting logistics, and assists with development of documents and standard forms.

RESPONSIBILITIES:

• Performs study activities including start-up, maintenance and close-out with other Clinical Operations team members’ oversight and guidance.

• Performs eTMF functional QC and CRO oversight QC.

• Performs study document upload to Trial Master File or other repositories.

• Reviews and participates in the quality assurance of data or documents.

• Assists with development of documents and standard forms.

• Arranges study meeting logistics, agendas, and assists with minutes

• Tracks and prepares study-specific information using databases, spreadsheets, and other tools.

• Maintains internal Clinical Operations databases, Tools and document repositories

• Supports administrating the budget and financial management of study activities, under responsibility of the executives concerned.

• May act as a local subject matter expert (SME) or SPOC for a specific focus area e.g. eTMF/TMF, CTMS, budget, document archiving, etc.

• Interacts with other departments, as needed, to complete assigned tasks.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

- Minimum Education & Experience

• Mandatory: 1 or more years’ relevant work experience – SSU (Study Start-up) or CTA (Clinical Trial Assistant) from Pharma/CRO or Study Coordinator from investigational sites.

• BA / BS / RN

• Some general clinical or business knowledge and experience is preferred.

Knowledge & Other Requirements

• Knowledge of local country regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures

• eTMF, CTMS & budget support experiences preferred.

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Understands how to use basic office programs / tools.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly matrixed environment.

• Ability to execute multiple tasks as assigned

• Excellent verbal and written in Korean and English skills, and interpersonal skills are required.

• Works proactively under minimal supervision.