Clinical Trials Administrative Coordinator

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

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.