Clinical Project Assistant (Training provided)l - HTJ

RECRUIT EXPRESS PTE LTD; Singapore; Hybrid; SGD 35,000 - 60,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is looking for a clinical project support professional to assist the clinical team with keeping study and site compliance within project timelines. You will help prepare and archive clinical documentation, track CRFs and data flow, and support regulatory submissions and safety reporting.

Ideal candidates hold a science-related bachelor degree and have some exposure to regulatory affairs or CTM. Training will be provided to ramp up on processes and documentation standards.

Qualifications

• Bachelor degree in science-related discipline.
• Experience or exposure in regulatory affairs or CTM.
• Training will be provided.

Responsibilities

• Maintain clinical systems tracking study compliance and performance within timelines.
• Prepare, handle, file, and archive clinical documents and reports.
• Review study files for accuracy and completeness and support project filing.
• Track CRFs, queries, and clinical data flow.
• Assist with regulatory submissions, safety report handling, and project logistics.
• Support project finance activities including expenses invoicing and site payments.
• Act as central contact for project communications with sponsor and vendors.

Skills

Regulatory affairs

Clinical trial management

Documentation handling

Project coordination

Education

Bachelor's degree in Science-related disciplines

Job description

Responsibilities

• Assist the clinical team with updating and maintaining clinical systems that track study & site compliance and performance within project timelines.
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
• Assist with periodic review of study files for accuracy and completeness and to support with project related filing.
• Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
• Assist in handling the project-related administrative matters, such as preparation for regulatory submissions, safety report handling, and other logistic issues.
• Assist with Project finance related activities including project expenses invoice preparation and tracking as well as site payment invoice review, preparation and tracking.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation including communication with sponsor and vendors as delegated. Support any other project related tasks as assigned.

Requirements:
min. Bachelor Degree in any Science related disciplines
Possess some prior working experience or exposure in regulatory affairs and/or clinical trial management
Training will be provided