Clinical Research Assistant — Hybrid & Start-up Support

Therapeutics Inc.; California; Hybrid; USD 67,000 - 69,000; Full time

Job summary

Therapeutics Inc. is seeking a Clinical Research Assistant to provide multi-task administrative support for clinical studies. The role involves start-up activities, regulatory document management, CTMS setup, and coordination with CRAs and study sites.

The position requires a scientific background (BS or equivalent), strong communication, and meticulous organization. The company emphasizes collaboration and a hybrid onsite work policy in San Diego-area operations.

Qualifications

• BS degree or equivalent knowledge and experience in a relevant field.
• Excellent written and oral communication skills with attention to detail.
• Comfortable navigating computer programs and multitasking effectively.

Responsibilities

• Assist in the start-up of new clinical studies with the study team to generate and obtain required study documents.
• Assist in set-up and maintenance of the central filing system for regulatory documents and study records.
• Maintain and track study site clinical supplies and related documentation.
• Assist staff in preparation and implementation of investigator meetings.
• Develop and maintain communication with internal and external departments and offices.
• Produce and distribute clinical meeting agendas and meeting minutes.
• Set up new studies in CTMS and track regulatory documents.
• Assist CRAs in TMF reviews and closeout binder preparation.
• Archive TMF and related project files for completed studies.
• Develop knowledge of therapeutic areas and regulatory guidelines (GCP, ICH).
• Demonstrate professional behavior and effective organizational skills.
• Support distribution of study communications and enrollment updates.

Skills

Scientific background

Communication skills

Detail-oriented

Computer skills

Education

BS degree or equivalent

Job description

Therapeutics Inc. is seeking a Clinical Research Assistant to provide multi-task administrative support for clinical studies. The role involves start-up activities, regulatory document management, CTMS setup, and coordination with CRAs and study sites.

The position requires a scientific background (BS or equivalent), strong communication, and meticulous organization. The company emphasizes collaboration and a hybrid onsite work policy in San Diego-area operations.