Clinical Project Associate

Sarah Cannon Research Institute•Usa, TN

1d•Remote

About The Position

The Clinical Project Associate is responsible for setting up and maintaining the Trial Master File (TMF) in audit-ready condition and conducting critical document collection and review throughout the study lifecycle. The role follows Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs. The associate also maintains clinical trial management systems and tracking tools and participates in cross-functional teams to support project deliverables. This is a remote position based in the United States; relocation assistance and visa sponsorship are not available.

Requirements

High school diploma or GED.
At least 1 year of clinical research experience.

Nice To Haves

At least 3 years of clinical research experience.
Oncology clinical research experience.

Responsibilities

Set up the TMF/eTMF and collect and upload files.
Perform initial quality reviews of documents before upload or filing in the TMF/eTMF.
Partner with the document specialist to maintain the TMF in audit-ready condition from study start through completion.
Assist in confirming investigator and investigative-site qualifications throughout the clinical trial.
Distribute critical documents to investigative sites and collect documents from them throughout the clinical trial lifecycle.
Proactively liaise with Clinical Research Associates and investigative sites to resolve outstanding regulatory issues.
Review study documents to ensure they are current, complete, and accurate.
Perform other duties as assigned.
Maintain clinical trial management systems and tracking tools.
Participate in cross-functional teams to support delivery of project deliverables.