Clinical Research Assistant

Therapeutics Inc. • San Diego, CA

8d • Hybrid

About The Position

Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. 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.

Requirements

• Scientific background (BS degree or equivalent knowledge and experience)
• Some experience in clinical research or the medical field or the education and passion to develop within the industry.
• Excellent written and oral communications skills
• Ability to handle multiple tasks easily
• Detailed-oriented
• Comfortable navigating computer programs

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level