Clinical Research Assistant

Therapeutics Inc.; San Diego (CA); Hybrid; USD 67,000 - 69,000; Full time

Job summary

Therapeutics, Inc. in San Diego seeks a Clinical Research Assistant to provide multi-task administrative support to clinical personnel for study implementation, including startup activities and regulatory document handling.

You will maintain the central filing system, track study supplies, assist in investigator meetings, and help coordinate communications across internal and external teams while ensuring compliance with GCPs and ICH guidelines.

Qualifications

• BS degree or equivalent knowledge/experience in clinical research or medical field.
• Excellent written and oral communications.
• Detail-oriented with ability to navigate 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 for regulatory documents and study records.
• Maintaining and tracking study site clinical supplies and associated documentation.
• Assisting staff in the preparation and implementation of investigator meetings.
• Developing and maintaining communication with internal and external departments/offices.
• Producing and distributing clinical meeting agendas and meeting minutes.
• Setting up new studies in CTMS and tracking regulatory documents.
• Assisting CRAs in preparing for study closeout by conducting TMF reviews and compiling closeout binders.
• Archiving TMF and related project files for completed studies.
• Developing knowledge of therapeutic areas through journals, seminars and reviews of protocols.
• Understanding procedures and standards of conduct for clinical studies including GCPs and ICH.
• Demonstrating professional behavior and effective organizational, planning and prioritization skills.
• Assisting in distribution of communications and recruitment materials to/from study sites.
• Assisting in tracking enrollment logs and weekly updates from study sites.
• Assisting in preparation of weekly team meeting project updates.

Skills

Scientific background

Communication skills

Detail oriented

Education

BS degree or equivalent

Job description

Who Are We?

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.

Who Are You?

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.

What is the Primary Objective of the Clinical Research Assistant?

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

Your Main Responsibilities and Duties Include:

• 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.

The most likely starting base pay range for this position is $66,500 to $68,650 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation. Candidates will be required to work onsite following our hybrid policy.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.