Description
We are seeking an Administrative Support professional to provide assistance to clinical projects under the direction of a line manager, Clinical Research Specialist, and/or other designated clinical team members.
Responsibilities
- Assist Clinical Research Specialists, Clinical Research Associates, and Regulatory and Start-Up teams with accurately updating and maintaining clinical systems to track site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures, and periodically review study files for completeness.
- Assist with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Track and manage Case Report Forms, queries, and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- May accompany Clinical Research Associates on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- Perform assigned administrative tasks to support team members with clinical trial execution.
Required Knowledge, Skills, and Abilities
- Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice and International Conference on Harmonization guidelines.
- Knowledge of applicable protocol requirements as provided in company training.
- Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.
- Good written and verbal communication skills, including good command of English language.
- Effective time management and organisational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Minimum Required Education and Experience
- High or Secondary School diploma/certificate or country's educational equivalent and 3 years administrative support experience; or equivalent combination of education, training, and experience.