Clinical Research Assistant
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Clinical Research Assistant is to provide multi-task administrative support to various clinical personnel for the implementation of clinical studies
MAJOR RESPONSIBILITIES AND DUTIES:
In this position the candidate will learn about clinical research and be responsible for the completion of multiple administrative tasks and associated procedures to support multiple studies.
• Assist in the start-up of new clinical studies, working directly with a study team to generate, distribute and obtain required study documents.
• Assist in the set-up and maintenance of the central filing system to ensure complete, accurate and current files of regulatory documents and study records.
• Maintain and track study site clinical supplies (drug, devices, etc.) and associated documentation.
• Assist staff in the preparation and implementation of investigator meetings.
• Develop and maintain communication with internal and external departments/offices.
• Responsible for the production and distribution of clinical meeting agendas and meeting minutes.
• Set up new studies in Clinical Trial Management System (CTMS) and track regulatory documents, CRFs and data queries within CTMS.
• Assist CRAs in preparing for study closeout by conducting TMF reviews and compiling closeout binders.
• Archive TMF and related project files for completed studies.
• Develop a knowledge of therapeutic areas associated with clinical studies through journals, seminars, review of clinical protocols, synopses etc.
• Develop 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.
• Demonstrate appropriate behavior in professional interactions
• Demonstrate effective organizational, planning and prioritization skills.
• Assist in distribution of communications, recruitment packages etc. to and from study sites.
• Assist in the tracking, filing and distribution of weekly updates of subject enrollment logs from the study sites.
• Assist in the preparation of weekly team meeting project management updates.
The candidate should have a scientific background (BS degree or equivalent knowledge and experience). At least 1 to 2 years' experience in clinical research or a combination of education and experience is preferred. Excellent written and oral communications skills, with the ability to handle multiple tasks and be detailed-oriented is mandatory. Familiarity with multiple computer programs is a plus.