Clinical Project Associate

Sarah Cannon Research Institute•Work at Home - Tennessee, USA (WTNA), TN

2d•Remote

About The Position

The Clinical Project Associate ensures the Trial Master File (TMF) is set up and maintained in audit-ready condition and conducts critical documentation collection and review throughout the study lifecycle. The work follows Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs. The associate maintains clinical trial management systems and tracking tools and participates in cross-functional teams to support delivery of project deliverables. This position is remote within the United States. Relocation assistance and visa sponsorship are not available.

Requirements

Minimum 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 uploading or filing them in the TMF/eTMF.
Partner with the document specialist to maintain the TMF in audit-ready condition from study start through completion.
Help confirm 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.
Maintain clinical trial management systems and tracking tools and participate in cross-functional teams to support project deliverables.
Perform other duties as assigned.