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Clinical Research Support Specialist
hace 1 semana
Job Overview
As a key member of the clinical research team, the successful candidate will perform daily administrative tasks to ensure the timely and accurate delivery of Trial Master Files. This role requires close collaboration with Clinical Research Associates and Regulatory and Start-Up teams to maintain accurate records and track site compliance.
Key Responsibilities:
- Assist Clinical Research Associates (CRAs) in updating and maintaining clinical documents and systems, including the Trial Master File (TMF), to ensure site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures.
- Review study files for completeness on a periodic basis.
- Support CRAs and Regulatory and Start-Up teams with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- Serve as a central contact for clinical team communications, correspondence, and associated documentation.
Qualifications:
- Degree in life science or related field.
- Clinical research experience is highly valued.
- Availability to work on a hybrid model with occasional travel to sponsor's office.
- Equivalent combination of education, training, and experience.
- Proficiency in Microsoft Office Suite, particularly Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, including fluency in English language.
- Effective time management and organizational skills.
- Able to establish and maintain effective working relationships with coworkers, managers, and clients.
- Familiarity with applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledge of applicable protocol requirements.
