Clinical Research Assistant

Primary Objective

You will provide multi-task administrative support to various clinical personnel for the implementation of clinical studies.

Main Responsibilities and Duties

• Assisting in the start-up of new clinical studies, working directly with a study team to generate, distribute and obtain required study documents.
• Assisting in the set-up and maintenance of the central filing system to ensure complete, accurate and current files of regulatory documents and study records.
• Maintaining and tracking study site clinical supplies (drug, devices, etc.) and associated documentation.
• Assisting staff in the preparation and implementation of investigator meetings.
• Developing and maintaining communication with internal and external departments/offices.
• Responsible for the production and distribution of clinical meeting agendas and meeting minutes.
• Setting up new studies in Clinical Trial Management System (CTMS) and tracking regulatory documents.
• Assisting CRAs in preparing for study closeout by conducting TMF (Trial Master File) reviews and compiling closeout binders.
• Archiving TMF and related project files for completed studies.
• Developing a knowledge of therapeutic areas associated with clinical studies through journals, seminars, review of clinical protocols, synopses etc.
• Developing an understanding of the procedures and standards associated with the conduct of clinical studies including a thorough knowledge of GCPs, ICH and other regulatory guidelines.
• Demonstrating appropriate behavior in professional interactions.
• Demonstrating effective organizational, planning and prioritization skills.
• Assisting in distribution of communications, recruitment packages etc. to and from study sites.
• Assisting in the tracking, filing and distribution of weekly updates of subject enrollment logs from the study sites.
• Assisting in the preparation of weekly team meeting project management updates.

To Succeed In This Position

• You should have a scientific background (BS degree or equivalent knowledge and experience) and some experience in clinical research or the medical field or the education and passion to develop within the industry.
• You should have excellent written and oral communications skills, with the ability to handle multiple tasks easily.
• You must be detailed-oriented and feel comfortable navigating computer programs.