Clinical Research Assistant

Responsibilities

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

Benefits

Hybrid work policy; candidates are required to work onsite following the policy.

San Diego, California, USA

http://www.therapeuticsinc.com

Growth Stage

Total Funding

$3M

2011-01-28

Series Unknown· $3M

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Qualifications

You are a dedicated individual who is passionate about your work

You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work

You believe anything worth doing, is worth doing right

You communicate clearly and have great attention to detail

You love to collaborate with the team but are able to think on your feet to problem-solve independently

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

Required skills

Represents the skills you have, click on the tags

Experience

Entry level