Clinical Research Assistant 1

Details:
Position Summary:
This position may be responsible for supporting the operational aspects of clinical studies. They will work closely with Clinical Affairs management, Clinical PMs, CRAs, relevant internal Dexcom functional groups and study coordinators to process the flow of clinical supplies, equipment and documents between a study site and client; and assure that the operational and regulatory aspects of the client sponsored trials are met. May work with various functional groups such as R&D, Biostatistics, Finance, Legal, Marketing, Quality Assurance, and Clinical Operations.
Essential Duties and Responsibilities:

• Maintains, organizes, prepares, and orders supplies and equipment required for clinical studies.

• Coordinate calibrations and preventative maintenance services for clinical equipment

• May assist with tracking supply costs

• Process timely shipping of clinical study supplies and equipment.

• May assist with the management of studies by supporting daily operations, including methods, workflow, and implementation of procedures.

• May assist in the set-up of IT equipment required for clinical studies.

• May assist with the testing of electronic data capturing systems.

• May serve as a supporting member for quality control of study-related documents and may be accountable for their correct distribution.

• May provide support to CRA personnel for preparing documentation, reports, and presentations.

• May coordinate study-related meetings, as needed.

• May perform scribe function during clinical meetings and produce meeting minutes for management review.

• May assist management with departmental audits of clinical studies and procedures.

• May create change order documents in company's document control system.

• May work with team(s) on managing assigned clinical tasks and deliverables to meet clinical timelines.

• Collaborates effectively with peers and leadership across departments.

• May coordinate maintenance of a tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body).

• May assists in the creation and maintenance of tracking mechanisms for all study-related supplies, equipment, documents, activities, and projects through all phases of the study.

• This position assumes and performs other duties as assigned.

• Will perform assigned tasks under direct supervision.

• Current GCP (Good Clinical Practice) Training.
• Clinical Trial Management System (CTMS) experience.

• None.
• Local to San Diego, California or willing to relocate.