Clinical Assistant 2

Position Summary:

Illumina is seeking a Clinical Assistant 2 who will join the Clinical Affairs department based in San Diego. This role will perform technical and administrative tasks supporting multiple clinical studies and clinical program managers across the international Clinical Affairs department, such as tracking purchase orders, building clinical study files, and reviewing clinical study documentation.

This role will support activities involved in planning, preparation for, and implementation of clinical trials to meet study timelines and conform with applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures. This role may also be responsible for reviewing data from active clinical studies.

As a member of the Chief Medical Officers Organization, this role contributes to integrating genetic, medical and laboratory principles in the application of clinical genome sequencing. This group plays a critical role in bringing genome sequencing to physicians as a tool for improving patient care.

All About You

Responsibilities:
* Ensure accurate submissions to in-house document control system (SAP) and track through to approval and effectivity.
* Ensure accurate submissions to vendor tracking system; pull required reports on vendors already in the system
* Initiate and track documents related to clinical studies and follow up as necessary to obtain signatures, get approvals, and ensure timely action, such as purchase requisitions, site communications.
* Obtain supplies as needed to support clinical studies
* Set up and maintain trial master files for clinical studies
* Study documentation for sites: generation, organization, and customization
* Maintain department-wide documents such as master protocol list
* Ship clinical study supplies to other Illumina offices and to clinical study sites
* Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions
* May assist in taking notes for meeting minutes
* May assist in file transfer for study data management
* May assist in remote review of study data for compliance
* Develop strong working relationships and maintain effective communication within the Clinical Department as well as other functional departments within the company.
* Participate in other project or departmental tasks as needed to ensure studies and publications are completed on time and within budget.
* Other duties and project support as assigned

Requirements:
* 1-2 years of relevant work experience in health care, biotechnology, or diagnostics.
* Previous experience in a similar role is preferred. Experience with in vitro diagnostics experience is a plus.
* Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
* Demonstrated ability to work independently and in a team environment. Flexible: adapts as needed to assist different teams, meet changing requirements & timelines.
* Demonstrated ability to deliver assignments on time.
* Computer proficiency (MS Word, Excel, Powerpoint) required. Experience with MS Access and MS Project a plus.
* Excellent oral and written communication skills, good command of written and spoken professional English, and strong organizational abilities.
* Travel required