Clinical Project Associate - Remote US

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

1d•Remote

About The Position

As the Clinical Project Associate, you are responsible for ensuring the Trial Master File (TMF) is set-up and maintained in “audit ready” condition; and conduct critical documentation collection and review throughout the lifecycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools, actively participating in cross-functional teams to ensure delivery of project deliverables. This position is remote based in the US; relocation assistance and visa sponsorship are not available.

Requirements

Minimum High School Diploma or GED
At least 1 year of clinical research experience required

Nice To Haves

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

Responsibilities

Set-up, document collection/upload of files to the TMF/eTMF
Perform initial quality review of documents prior to upload/filing in the TMF/eTMF
Partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion
Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial
Perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues
Review study documents to ensure they are current, complete and accurate
Other duties as assigned