Clinical Research Associate (REMOTE)

Notes from the Manager:

• CRA experience in IVD (at a minimum) in CDx

• On-site monitoring experience in IVD/CDx, 1-5 years.

• Performs all study monitoring visits and completes supporting visit reporting, including site initiation, interim monitoring, remote monitoring, and close-out visits. 

• Collect and review site regulatory and essential documents for accuracy and completion. Maintain study Trial Master File (TMF)/or eTMF and ensure Investigator Site Files (ISFs) are current and maintained.

• Performs IUO or RUO inventory and accountability, in accordance with study monitoring plan. Facilities return or destruction of any IUO/RUO material as required.

• Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings.

• Ensures TMF/ISF is audit ready.

• It can be fully remote but must work in PST timezone.

• For this position, it is more of a specialist role, so their day-to-day won t be typical.

• The ideal candidate for this role would have at least 5 years of experience as a CRA and may already have some CTM experience.

• It will also help if they have some QA experience.

• Clinical coordinators would not work.

Job Posting Qualifications

• Bachelor's or Master's Degree or equivalent.

• Post-graduate, certification, and/or license may be required.

• Typically, at least 3 - 5+ years relevant experience.

Job Posting Description

Responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies.

• Coordinates Ethical Committee and Institutional Review Board notifications.

• Creates, maintains and oversees study files and archiving.

• Manages testing laboratories including selection of laboratories for the studies.

• Manages clinical research organizations and ensures monitoring of studies, data collection and handling.

• Prepares, revises and maintains procedures for the conducting of clinical studies.