Clinical Research Assistant

San Diego, California
Oct 23, 2017
Required Education
Bachelors Degree
Position Type
Full time

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

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.