Senior Clinical Trials Assistant
- Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Collaborate with Clinical Project Manager (CPM), CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness.
- Collaborate with CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.
- May accompany CRAs 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.
- Bachelor’s degree in life science or related field and 3-4 years clinical research experience, or equivalent combination of education, training and experience.
- Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local regulations.
- Knowledge of applicable protocol requirements as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Effective written and verbal communication skills including good command of English language
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers, Project teams and site staff.
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