Clinical Research Administrative Specialist

Therapeutics,-Inc.; San Diego (CA); Hybrid; USD 67.000 - 69.000; Vollzeit

Zusammenfassung

Therapeutics, Inc. in San Diego is seeking a Clinical Research Assistant to provide multi-task administrative support for clinical studies. You will help with regulatory documents, CTMS entries, and TMF organization, ensuring study records are accurate and current.

You will collaborate with study teams, coordinate meetings, and maintain communications with internal and external partners while applying GCP/ICH standards. The role is onsite with hybrid policy guidance.

Qualifikationen

• Scientific background with BS or equivalent knowledge.
• Excellent written and oral communication skills.
• Detail-oriented with ability to manage multiple tasks.

Aufgaben

• Assist in start-up and regulatory document handling for new studies.
• Maintain central filing system for regulatory docs and study records.
• Track study site supplies and related documentation.
• Prepare and support investigator meetings and project updates.
• Set up studies in CTMS and monitor regulatory documents.
• Assist with TMF reviews and study closeout activities.

Kenntnisse

Excellent written and oral comms

Detail-oriented

Multitasking

Computer proficiency

Ausbildung

BS degree or equivalent knowledge and experience

Tools

CTMS

Microsoft Office

Jobbeschreibung

Therapeutics, Inc. in San Diego is seeking a Clinical Research Assistant to provide multi-task administrative support for clinical studies. You will help with regulatory documents, CTMS entries, and TMF organization, ensuring study records are accurate and current.

You will collaborate with study teams, coordinate meetings, and maintain communications with internal and external partners while applying GCP/ICH standards. The role is onsite with hybrid policy guidance.